Engineering Jobs in Dayton New Jersey

Organize, train and oversee technical staff in order to implement established maintenance, inspection and operational procedures. Must have proven skills in problem-solving and team building. Be able to schedule work, repair, and maintain machines, equipment and facilities to ensure safe, reliable, and consistent operation according to the manufacturer’s requirements.

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Duties and Responsibilities:

Must be knowledgeable and have basic understanding of mechanical, hydraulic and pneumatic systems including (but not limited to) the following areas:

• Manage union team members and oversee various jobs and projects.
  • Monitor communication methods for additional work assignments, upcoming events, and internal communications.
  • Ability to understand mechanical, hydraulic, and pneumatic drawings.
  • Understanding of Building construction plans.
  • Identify suppliers for replacement parts, obtain competitive bids, and enter purchase requisitions.
  • Use test data and electrical schematics to troubleshoot malfunctioning equipment.
  • Make recommendations regarding the need for modification to maintenance procedures, test procedures, instrumentation or setup based upon test results and machine operational performance.
  • Work in co-operation with engineering, technical and management or outside personnel.
  • Maintain detailed maintenance records in order to perform effective preventive maintenance.
  • Maintain good Maintenance standards to ensure buildings, grounds and attractions are safe and visually in compliance.
  • Have the ability to plan, organize and train a maintenance team for a large Theme park, Safari, and waterpark.
  • Must have the ability to train safety, OSHA and protocol information to large groups and document the trainings.
  • Must possess the ability to stand for long periods of time, climb stairs and ladders repeatedly, bend, stoop, twist, crawl, kneel, push, pull, and work overhead using both hands.

Distek is seeking a motivated Bioprocessing Account Manager to join our growing sales team. This role is specifically designed for candidates with 1–3 years of experience in life sciences sales or technical customer-facing roles who want to develop their skills in bioprocessing sales. 

Based in DC, DE, MD, NJ or Eastern PA, this position focuses on expanding BIOne benchtop bioreactor sales across the East Coast. You’ll work directly with customers to understand their applications, support product evaluations, and build long-term relationships—while learning Distek’s sales process, products, and market approach.

Responsibilities

• Develop and implement sales and marketing strategies to grow BIOne Bioreactor sales on the East Coast.
• Identify and generate leads through research, cold calling, trade shows, and networking
• Lead technical sales calls, schedule and conduct demonstrations, and manage product evaluations
• Collaborate with product line management and administration to prepare quotations
• Close BIOne orders and support customer satisfaction throughout the sales process
• Proactively follow up with customers post-sale
• Participate in trade shows and stay informed on bioprocessing industry trends
• Prepare and submit accurate quotations
• Perform all responsibilities in accordance with ISO standards and internal procedures

Qualifications

• Bachelor’s degree in Life Sciences (Biology, Cell Biology, Biochemistry, Engineering) or equivalent experience
• Prior upstream bioreactor experience (cell culture or fermentation) is required
• 1–3 years of direct sales experience in the life sciences industry is required
• Experience engaging customers through sales calls, presentations, or training
• Ability and willingness to travel at least 60–70% within the assigned territory is required

Skills

• Self-motivated with the ability to work independently
• Strong organizational and prioritization skills
• Excellent written and verbal communication abilities
• Proficiency in Microsoft Office and CRM tools
• Team-oriented mindset

Company Offerings

• Career growth
• Medical / Dental / Vision
• 401(k) Plan
• Generous Holiday Schedule
• Vacation & Sick time
• Positive company culture
• Competitive Compensation

In this role, you will report to the Site Manager and will work closely with the Avantor's Advanced Laboratory Services professionals to serve our customers by performing customized, mission-based lab work and research protocols that help return time back to science.

Location: Somerset, NJ

Shift: 8 am-4:30 pm (may change based on customer needs)

Hourly Rate: $23.00 - $25.00

Benefits:

• Health and Wellness: Medical, Dental, Vision, and Wellness programs

• Time Off: Paid Time Off (PTO), Company-paid holidays, Choice holidays, etc.

• Financial Well Being: Spending Accounts: Flexible Spending Account (FSA), Health Savings Accounts (HSA), commuter benefits, 401(k), tuition assistance, employee stock purchase plan discount

• Added Protection Coverage: To include critical illness, hospital indemnity, accident, legal, identity theft protection, pet, auto, and home insurance

• Recognition: Celebrate your peers and earn points to redeem for gifts and products

What we're looking for

• Education:

• High school diploma required; Associate's or Bachelor's degree in Supply Chain, Logistics, Life Sciences, or related field preferred.

Experience:

• 1-2 years in procurement, inventory management, or lab operations required.

• SAP, MS Office Suite (Excel, Access), and digital procurement platforms preferred.

• Collaboration Tool: Microsoft Teams experience preferred

• Formal training in problem-solving methodologies is preferred.

• Familiarity with FDA, CGMP, and ISO standards.

• Strong understanding of lab operations and material workflows.

• Ability to independently solve complex problems using operational insights.

• Excellent organizational and multitasking skills.

• Effective communicator with strong interpersonal and negotiation abilities.

• Proficient in data analysis and reporting,

• Proficiency with MS Office Suite (Expert-level skills in Excel)

• SAP experience is highly desirable.

• Knowledge of contracts and supplier management best practices.

• Comfortable working in highly regulated environments.

How you will thrive and create an impact

Avantor's Advanced Laboratory Services team is a crucial part of the Avantor Services group serving over 500 customers in biopharma, pharmaceutical, educational, industrial, and high-tech industries with customizable, flexible solutions and end-to-end laboratory operations support.

As an Onsite Procurement Specialist/Buyer, you'll be embedded at customer facilities to ensure the seamless coordination of inventory and material operations. This role supports laboratory and production environments by managing sourcing, procurement, and logistics of essential materials, including consumables, chemicals, solvents, and reagents. You'll be the operational backbone of our onsite services, helping our customers maintain efficiency, compliance, and scientific progress. In this role, you will:

• Coordinate and streamline workflows related to inventory and material management.

• Support procurement and planning functions, ensuring timely and compliant delivery of materials.

• Maintain strong relationships with vendors and internal departments to optimize cost, quality, and delivery timelines.

• Ensure alignment with regulatory standards, including FDA, CGMP, and ISO9001.

• Collaborate with Avantor's broader service and sourcing teams to deliver integrated solutions.

• Source, procure, and coordinate delivery of critical lab and production materials.

• Manage inventory levels, reorder points, and replenishment cycles using Avantor and customer systems.

• Assist in supplier qualification, contract interpretation, and compliance documentation.

• Support emergency deliveries and installation of materials.

• Maintain standing orders and manage engineering change notifications.

• Provide reporting on material planning, open orders, and performance metrics.

• Resolve non-conformance issues and document supplier corrective actions.

• Facilitate audit support and vendor engagement activities.

• Collect, document, and report operational data and observations.

• Maintain >95% inventory accuracy across managed categories.

• Achieve an on-time delivery rate of >98% for critical materials.

• Ensure 100% compliance with regulatory and safety standards.

• Deliver monthly reports on inventory levels, supplier performance, and cost savings.

• Perform other duties as assigned.

• Resolve procurement issues within 48 hours of escalation.

• Maintain positive customer satisfaction scores through responsive service and communication.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Our employer is a leading provider of premium metal payment cards and secure authentication solutions. Headquartered in Somerset, New Jersey, the company serves major financial institutions, producing over 30 million metal cards annually and holding a dominant share in the premium metal card segment. It also offers advanced digital security through a proprietary platform that includes three-factor authentication and cold storage for digital assets, generating over $420 million in annual sales.

• Salary range: 85-150k USD
• Annual Bonus: Up to 15% (contingent upon a combination of company's and personal performance).

Position Summary

We are seeking an Advanced Manufacturing Engineer (Automation) who will perform the planning, design, and implementation of automation solutions across our production lines. This role involves designing and building custom machines in-house as well as managing external integrators to deliver turnkey automation systems. The ideal candidate will have a proven track record in machine design, supplier management, and project execution in high-volume manufacturing environments.

This position is critical to driving automation initiatives that improve efficiency, scalability, and quality in a multi-million-unit-per-year production setting.

Key Responsibilities

• Automation System Design & Implementation
• Design and develop custom automation equipment using SolidWorks.
• Lead full lifecycle of automation projects: concept, design, build, installation, and validation.
• Collaborate with external integrators and manage suppliers for outsourced machine builds.
• Production Line Automation
• Plan and implement automation solutions for assembly and packaging lines.
• Integrate robotics, PLCs, vision systems, and material handling equipment.
• Project Management
• Develop project timelines, budgets, and resource plans.
• Ensure projects meet performance, quality, and safety standards.
• Safety & Compliance
• Ensure all automation systems comply with OSHA, environmental, and company safety standards.
• Implement risk assessments, machine guarding, and lockout/tagout procedures.
• Maintain documentation for regulatory compliance and audits.
• Continuous Improvement
• Identify automation opportunities to reduce labor, improve throughput, and enhance quality.
• Drive cost reduction and efficiency initiatives through innovative automation solutions.

Qualifications

• Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field.

Experience

• 5+ years of hands-on experience in machine design and automation engineering.
• Proven track record of designing, building, and installing machines in high-volume manufacturing environments.

Technical Expertise

• SolidWorks proficiency for machine and fixture design.
• Strong knowledge of automation technologies: robotics, PLC programming, vision systems, conveyors, and material handling.
• Experience with supplier management and working with external integrators.
• Understanding of system design, defect analysis, and process optimization.
• Familiarity with SPC, Six Sigma, and DoE methodologies for data-driven improvements.
• Ability to troubleshoot automation and mechanical issues, conduct root cause analysis, and implement corrective actions.

Preferred

• Experience designing full production lines.
• Familiarity with high-speed automation for multi-million-unit production.
• Knowledge of Lean Manufacturing principles.
• Exposure to ISO 13485 or automotive quality standards.
• Experience with robotic integration, automated quality inspection, and vision systems.

Our employer believes in supporting our employees with a comprehensive benefits package that promotes health, financial well-being, and work-life balance. Our full-time team members enjoy access to:

• Medical, Dental & Vision Coverage
• Flexible Spending Accounts (FSA)
• Company-Paid Life and Disability Insurance
• 401(k) with Company Match
• Paid Time Off & Paid Holidays
• Annual Bonus Opportunities
• Employee Assistance Program (EAP)
• Career Advancement Opportunities

**** Benefits eligibility and details will be shared during the hiring process.

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.

The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.

Key Responsibilities

• Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.

• Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.

• Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.

• Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.

• Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.

• Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.

• Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.

• Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.

• Minimum 1 year of leadership, supervisory, or management experience (preferred).

• Prior experience in manufacturing, quality, or engineering is required.

• Excellent communication, leadership, and organizational skills.

• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

• Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.

Preferred Qualifications

• Experience with cell therapy automation technologies, closed-system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.

• Hands-on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.

Physical Requirements

• Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Regular, punctual attendance is required.

• Must be willing to be gown-qualified and work in CNC/ISO8/ISO7 cleanroom environments.

• Must be able to lift up to 25 lbs.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be able to sit or stand for extended periods.

• Must be willing to work with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Manufacturing Associate will support Cell Therapy Operations at our GMP-compliant facility, playing a critical role in the production of cutting-edge cell therapies. This position is ideal for a detail-oriented professional with strong aseptic technique and a proven ability to quickly master complex processes in a cleanroom environment. The successful candidate will demonstrate a deep commitment to current Good Manufacturing Practices (cGMP) and thrive in a collaborative, quality-driven setting. This role requires precision, adaptability, and a strong quality mindset to ensure the consistent delivery of high-standard therapeutic products.

Key Responsibilities

• Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring compliance with all cGMP and safety standards.

• Execute complex procedures for cell therapy manufacturing and sterile product operations—including cell culture, formulation, and cryopreservation—while maintaining strict adherence to written procedures, batch records, and cGMP regulations.

• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and functionality.

• Monitor and document all production processes with precision, ensuring traceability and compliance with regulatory standards.

• Identify and escalate deviations or non-conformances; participate in root cause analyses and implement corrective actions.

• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to support continuous improvement initiatives.

• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and sterilization activities.

• Maintain an organized, compliant workspace by following 5S principles and minimizing contamination risks.

• Participate in training sessions to stay current with manufacturing techniques, quality standards, and safety protocols.

• Support process development activities during technology transfer.

• Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods.

• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).

• Review MBRs daily to ensure documentation is accurate and complete.

• Participate in audits, inspections, qualifications, and validation activities.

• Handle chemicals such as corrosives, solvents, and biohazardous materials safely.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Biology, Biotechnology, or a related field preferred; equivalent experience will be considered.

• 1–3 years of experience in GMP manufacturing, preferably in cell therapy, biologics, or pharmaceutical CDMO operations.

• Strong knowledge of aseptic techniques and cleanroom protocols.

• Proficiency in basic mathematical concepts, including scientific notation.

• Proven ability to learn and master complex processes quickly.

• Exceptional attention to detail with a strong commitment to quality standards.

• Excellent collaboration, communication, and interpersonal skills.

• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.

Preferred Qualifications

• Experience in aseptic cell culture processing in ISO 5 biosafety cabinets, using universal precautions for handling human-derived materials.

• Familiarity with cell therapy automation technologies, closed system culture vessels, cell washers, and cell separation technologies for autologous or allogeneic product manipulation.

• Experience handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells.

• Proficiency in basic computer applications (e.g., Microsoft Office, electronic batch record systems).

Physical Requirements

• Ability to stand for extended periods and perform repetitive tasks in a cleanroom environment.

• Must be able to lift up to 25 lbs. and work in full cleanroom gowning and PPE for extended durations.

• Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be comfortable working with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available for shift work, including off-shift hours, weekends, and holidays, as needed to meet production demands. Flexibility to accommodate changing production schedules is required.

*Duration: 7 months contract

Job Description:

• The Quality Analyst is responsible for the oversight and execution of Quality Management Systems and compliance at the Distribution Center. The Quality Analyst serves as a single point of contact to the Sr. Manager, Janssen Commercial Quality and Supply Chain partners on compliance related matters and is the liaison with multiple Quality and Compliance organizations to drive timely resolution of quality and compliance related issues. The Quality Analyst identifies business issues, identifies opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions. The Quality Analyst implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.

Responsibilities:

• Quality and compliance product receiving process, including, but not limited to receiving inspection activities such as review of temperature monitoring devices and systematic transactions in Warehouse Management System and/or SAP
• Monitoring and following Quarantine/Hold/Stop-Ship/Recall processes and notices
• Product refusals process activities, including, but not limited to inspection and disposition
• Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues
• Responsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management Systems
• Responsible for adherence to the Records Management and Retention processes
• Responsible for adhering to the Training process
• Supporting internal and external audits
• Plans, support, and coordinates quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the duties personally
• Provide quality and compliance oversight for execution of Protocols
• Notify/escalate critical quality issues to management in a timely manner
• Provide data/information/metrics to management for Quality System Management Reviews
• Develop and review of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as needed
• Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner
• Identifies opportunities to continuously improve quality, cost and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives
• Identify business issues, communicates to management, prioritizes for action, and leads improvement opportunities and problem solutions in collaboration with other Supply Chain partners.
• Perform gap assessments in local procedures to client Global Standards, Business processes, and External Standards
• Support of New Product Launch activities at the Distribution Center, including, but not limited to Master Data (sIDMa) set-up
• Ensures compliance and remaining current with local, state, federal, and international regulations and standards
• Evaluate the overall compliance risk and recommending corrective actions and tracking progress
• Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs
• Compliance oversight for the end-to-end clinical supply chain processes, including, but not limited to re-stickering and other labeling activities
• Compliance oversight for the end-to-end Re-Pack-Re-Label processes, including, but not limited to Batch Record/Protocol activities
• Monitor and review temperature data for the Distribution Center and ancillary areas
• Supports 24/7 operations of the Distribution Center
• Operate in a team-based environment with minimum supervision
• Provide training to new hires (FTEs) and/or Contractors
• Interface collaboratively with other business partners and stakeholders

Experience:

• A minimum of 2 years of experience in a highly regulated industry is required.
• Quality and Compliance experience in the Medical Device, Pharmaceutical or Consumer products industry and experience in distribution is preferred.
• Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required.
• Experience with Warehouse Management Systems and SAP is preferred.
• Experience with Quality Management Systems such as COMET is preferred.
• Proficiency in organizational and project management skills is preferred.
• Experience with Temperature Control is preferred.
• This position may require up to a 10% of domestic travel.
• Location can be Shepherdsville, KY or Somerset, NJ

Skills:

• Quality Management system

Education:

• A minimum of bachelor’s degree in an Engineering, Life Science, and Technical scientific or related discipline is preferred. In absence of a bachelor’s degree, special consideration would be considered for individuals who have related and background experience.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Azhar

Email:

Internal Id: 26-04181

Job Title: Bid Manager / Project Controller

Location: Piscataway, New Jersey

Salary: Up to $110,000 (based on experience)

Full-Time | Competitive Benefits

Join Our Team in Piscataway, NJ

We are seeking a detail-oriented and strategic Bid Manager / Project Controller to join our growing team in Piscataway - the right candidate will be incredibly detail oriented. This role is ideal for a professional who excels at managing bids, overseeing project financials, and ensuring operational excellence from proposal through execution.

With a competitive salary of up to $110,000, this is an excellent opportunity to play a critical role in driving project success and business growth.

Key Responsibilities

• Excellent and proven attention to detail. The rest can be taught!
• Lead and coordinate the end-to-end bid and proposal process
• Prepare cost estimates, pricing models, and financial analyses
• Develop and maintain project budgets, forecasts, and cost controls
• Monitor project performance against financial and operational targets
• Identify risks and implement mitigation strategies
• Collaborate with engineering, operations, finance, and leadership teams
• Support contract negotiations and ensure compliance with client requirements
• Produce detailed reporting for senior management and stakeholders

Qualifications

• Bachelor’s degree in Business, Finance, Engineering, or related field
• 3+ years of experience in bid management, project controls, or financial project oversight
• Strong financial acumen and analytical skills
• Experience with budgeting, forecasting, and cost tracking
• Excellent organizational and communication skills
• Proficiency in Excel and project management software
• PMP or similar certification (preferred but not required)

Princeton Theological Seminary, established in 1812, is dedicated to forming Christian leaders to serve Christ's church, academia, and the world. Located in Princeton, NJ, the institution is renowned for its commitment to theological education and fostering a community of faith and learning. The Seminary combines academic excellence with a rich history, providing an environment for students to grow spiritually and intellectually. With a global perspective, it prepares faith-driven leaders for impactful service.

This is a full-time, on-site Electrician role based in Princeton, NJ. The Electrician will perform installation, maintenance, and repair of electrical systems and equipment across campus facilities. Responsibilities include diagnosing and troubleshooting electrical issues, performing routine preventative maintenance, ensuring code compliance, and collaborating with the facilities team to uphold safety standards. The candidate will be required to handle various electrical tasks, ensuring operational efficiency for a safe environment.

• Proficiency in Electrical Work and Electricity, with the ability to install and maintain electrical systems
• Strong background in Maintenance & Repair tasks, ensuring equipment functionality and safety
• Skilled in Troubleshooting, identifying, and resolving electrical issues efficiently
• Understanding of Electrical Engineering principles and code compliance
• Excellent problem-solving and organizational skills
• Relevant certifications and licenses to perform professional electrical work
• Ability to work independently and collaboratively as part of a team
• Prior experience in facility management or academic settings is a plus

PilotCBP Air Interdiction Agent

NEW RECRUITMENT AND RETENTION INCENTIVES!

Air and Marine Operations (AMO), a component of U.S. Customs and Border Protection (CBP), offers skilled Pilots interested in law enforcement an opportunity to work with an elite team of highly trained professionals whose camaraderie, pride, and purpose are hallmarks of their daily mission to protect America.

If you are looking for an exciting and rewarding career with excellent pay, exceptional federal benefits and job stability, now is the time to make your move: become an Air Interdiction Agent. AMO is actively recruiting for these full-time security-based opportunities with a streamlined application process. Notably, seasoned pilots and those with military training are in demandAPPLY TODAY!

DONT FORGET TO CHECK OUT THE INCENTIVES SEE SALARY SECTION BELOW!

Duty Locations

Locations are offered based on operational requirements, mission requirements, and critical agency hiring needs as determined by AMO. You must be willing to work at any duty location within the region you select to include but not limited to the following:

Southeast Region:Homestead, FL and CAMB:Aguadilla, PR

Southwest Region: Tucson and Yuma, AZ; San Diego, CA; El Paso, Laredo, and McAllen, TX

NASOC UAS locations:Sierra Vista, AZ; San Angelo, TX

Duties and Responsibilities

As an Air Interdiction Agent (AIA) you will perform aviation-based law enforcement operations for the detection, prevention, interdiction, and apprehension of terrorists, terrorist weapons, and other contraband and persons from illegally entering or attacking the United States. Typical duties include:

• Conducting air patrol, surveillance, and pursuit activities related to the interdiction of smuggled contraband via land vehicles, aircraft, or vessels.
• Monitoring behavior patterns and activities of suspect persons, vehicles, or vessels believed to be engaged in illegal activities.
• Collecting, refining, and analyzing strategic and tactical intelligence.
• Supporting search and rescue and humanitarian efforts.

Salary and Benefits

Begin your career as an Air Interdiction Agent (AIA) and make up to $85,270 to - $110,846 per year based on your qualifications for the GS-11 grade level and possible extra compensation based on your duty location (see below).

Recruitment Incentive:New hires may be eligible to receive a one-time Recruitment Incentive payout of $10,000 after completing Federal Law Enforcement Training Academy (FLETC) (1 year service agreement will need to be completed) (Recruitment Incentive is only available to new Federal employees as described in 5 CFR 575.102. Eligibility will be determined by Human Resources.)

Your starting salary will include Special Salary Rate (SSR); Law Enforcement Availability Pay (LEAP); Recruitment Incentive; and Retention Incentive.

This career ladder position has a grade level progression of GS-11, GS-12, and GS-13. You may be eligible for a promotion to the next higher grade level automatically (without re-applying) once you complete 52 weeks at each grade level (with supervisor approval).

Example of annual compensation for the first three years at our new-hire locations which are currently authorized to receive LEAP (amounts below include the SSR + LEAP).

• GS-11, 1st year annual pay - $106,588
• GS-12, 2nd year annual pay - $127,754
• GS-13, 3rd year annual pay - $151,918

Example of annual compensation for the first three years at our new-hire locations which are currently authorized to receive a 10% Retention Incentive (amounts below include the SSR + LEAP + 10% Retention Incentive UAS Sites: Sierra Vista, AZ; Grand Forks, ND; San Angelo, TX).

• GS-11, 1st year annual pay - $115,115
• GS-12, 2nd year annual pay - $137,974
• GS-13, 3rd year annual pay - $164,071

Example of annual compensation for the first three years at our new-hire locations which are currently authorized to receive a 25% Recruitment Incentive (amounts below include the SSR + LEAP + 25% Recruitment Incentive CAMB location only; Aguadilla, PR).

• GS-11, 1st year annual pay - $127,906
• GS-12, 2nd year annual pay - $153,305
• GS-13, 3rd year annual pay - $182,302

Retention Incentive: Retention Incentive is contingent on eligibility. Eligibility will be determined by Human Resources.

• RI: Retention Incentive (25% for UAS Sites, Sierra Vista, AZ, Grand Forks, ND, San Angelo, TX)

• RI: Retention Incentive (25% for Key West, FL)

RI: Retention Incentive (25% for Caribbean Air and Marine Branch (CAMB) and subordinate locations)

Air Interdiction Agents are eligible to select from an array of federal employment benefits that include health, dental and other insurance plans, a generous annual and sick leave program, and participation in the Thrift Savings Plan, a retirement plan akin to a traditional and ROTH 401(k) offering.

Qualifications

Experience:You qualify for the GS-11 grade level if you possess one (1) year of specialized professional aviation experience performing duties such as:

• Flying as a Pilot-in-Command or sole manipulator in an airplane and helicopter in all environments of flight, including night, poor weather, unfavorable terrain, low altitudes, or speed.
• Evaluating information rapidly and making judicious decisions promptly during in-flight operations.
• Developing strategies and coordinating aircraft and ground assets.
• Using information systems and databases to conduct information surveys, queries, update files and disseminate information.
• Experience may include Operation of an aircraft as Captain, Pilot in Command, Aircraft Commander, First Officer, Certified Flight Instructor, Second in Command, or Co-pilot.

Hiring Minimums:

Certification & Ratings: A current FAA Commercial or ATP Pilot Certification with one of the following ratings:

• Dual Rated: Airplane (Single-engine land or multi-engine land) with instrument rating AND Rotorcraft Helicopter with instrument rating.
• Airplane Rated: Airplane (Single-engine land or multi-engine land) with instrument.
• Helicopter Rated: Rotorcraft Helicopter with instrument rating.
• Equivalent military rating of the above at the time of application (eligibility based on military flight experience must provide official orders, forms or logbooks showing their status as a rated military pilot).

Flight Hours: Pilot Enter on Duty minimums are 1500 flight hours; (up to 500 hours can be waived, reducing the pilot enter on duty minimums to 1000 hours.

250 Pilot-in-Command hours; 75 Instrument hours; 75 Night hours (Flight Hour Waiver available, see Required Documents); and 100 Flight hours in the last 12 months This qualification requirement is currently being waived by OPM through August 5, 2025.

FAA Class 2 medical required for assessment dated within the last 12 calendar months; FAA Class 1, FAA Class 2 or Military medical flight clearance dated within the last 12 months qualifies to start the pre-employment process for the AIA position.

Apply at 750 hours total time: Applicants applying at 750 flight hours are required to obtain at least 1,000 flight hours (depending on the number of hours approved for a waiver) at their own expense before being able to attend the 3-part flight assessment. Applicants must still meet 250 Pilot-in-Command, 75 instrument, and 75-night hours (100 flight hours in the last 12 months. This qualification requirement is currently being waived by OPM through August 4, 2026)

UAS Flight Hours:Applicants may include UAS Predator A (MQ-1), Predator B (MQ-9) flight hours and Predator A (MQ-1), Predator B (MQ-9) or predator-based flight hours. These hours may be credited towards satisfying the ""Total flight time"" 1,500 flight hour requirement only. UAS hours do not count towards the 250 flight hours as a Pilot in Command, 75 flight hours Instrument, and 75 flight hours Night. Flight hour logbooks will be required at the time of your Flight Assessment for verification.

Other Requirements

Citizenship: You must be a U.S. Citizen to apply for this position.

Residency: You must have had primary U.S. residency (includes protectorates as declared under international law) for at least three of the last five years.

Age Requirement: Provisions of Public Laws 93-350 and 100-238 allow the imposition of a maximum age for initial appointment to a primary Law Enforcement Officer position within the Department of Homeland Security (DHS). In accordance with DHS Management Directive 251-03, the ""day before an individual's 37th birthday"" is the maximum age for original appointment to a position as a primary law enforcement officer within DHS. The age requirement is also necessary to ensure that you are able to complete the 20 years of applicable service for retirement.

NOTE: The Commissioner of CBP has approved a temporary increase in the maximum allowable age to 40 for original placement into an Air Interdiction Agent position.

Age Waiver: Creditable law enforcement officer service -Covered by Title 5 U.S.C. 8336(c) or Title 5 U.S.C. 8412(d), or creditable service covered by Title 5 U.S.C. 8401(36) (as a Customs and Border Protection Officer) on or after July 6, 2008, may be applied toward the maximum age requirement. This age restriction may not apply if you are currently serving in a federal civilian (not military) law enforcement position covered by Title 5 U.S.C. 8336(c) or Title 5 U.S.C. 8412(d).

Veterans' Preference Eligibility: To ensure compliance with statutes pertaining to the appointment of preference eligible veterans as determined by the Merit Systems Protection Board in its decisionIsabellav.Dept of State,the maximum age for original appointment articulated above shall not apply to the hiring of individuals entitled to veterans' preference eligibility under 5 U.S.C. 3312. You must submit proof of Veteran's Preference (DD-214 Member 4 Copy) at the time of application.

Training:This position has a training requirement. You may be required to successfully complete the training requirement as a condition of employment. Failure to successfully complete the required course(s) of training in accordance with CBP standards and policies will result in placement into either a former or different position, demotion, or separation as determined by management and appropriate procedures.

Travel Required: You may be expected to travel for this position based on operational needs.

How to Apply

There Are Three Ways to Apply to Become an Air Interdiction Agent:

• Fill out theAir Interdiction Agent applicant checklistand email it to a recruiter at along with a copy of your resume; OR

• Apply onUSAJOBS;OR

• Apply onAirline Apps.

Stay Updated Opt into CBPs talent repository (highly recommended) by selecting the Contact a Recruiter button. For Position of Interest select Air and Marine Operations, Air Interdiction Agent, then complete the pre-screening questions. Youll receive monthly emails with information about webinars, career expos, and future opportunities with AMO and CBP.

• Government & Military

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Location: 160 Princeton Hightstown Road, East Windsor NJ 08520

Rate of Pay: Rate of pay: $84,469 - $103,320 per year

Job Overview

The Warehouse Management Systems (WMS) Analyst serves as the on-site liaison between the operations management team and the Information Technology team, and plays a role of a super user in the utilization of the system. They would be responsible for day-to-day system maintenance and troubleshooting. First point of contact for assistance, questions, issues, training others, etc. at the operations level. Work with Operations teams, IT, and Engineering groups to ensure optimal configurations for WMS conversions, enhancements, and new business requirements.

Job Responsibilities and Essential Duties

• 
  
• Conduct organizational studies and evaluations, design systems and procedures, conduct work simplification and measurement studies, and prepare operations and procedures manuals to assist management in operating more efficiently and effectively. Includes program analysts and management consultants.
  
• Serves as the on-site liaison between the Operations Management and Information Technology teams, acting as a super user of the Warehouse Management System (WMS).
  
• Responsible for day-to-day system maintenance and troubleshooting, and functions as the first point of contact for operational-level assistance, including user questions, issues, and training. Collaborates with Operations, IT, and Engineering teams to ensure optimal system configurations for WMS conversions, enhancements, and new business requirements.
  
  

Minimum Requirements

• 
  
• Bachelor's degree in a STEM field plus 3 years of experience in warehouse management systems, or related.
  
• A minimum of 3 years of related systems experience.
  

Required Knowledge, Skills, and Abilities

• 
  
• Requires skills and experience to involve: Expert-level knowledge of Blue Yonder WMS from an operational perspective, including data mining, issue investigation, system adjustments, and development of best practices.
  
• Hands-on experience managing warehouse zones, including movement paths, storage zones, pick zones, and count zones, to ensure efficient workflow and inventory accuracy.
  
• Proven ability to troubleshoot RF (radio frequency) issues, ensuring minimal disruption to daily operations. Expertise in barcode configuration and management, supporting accurate and efficient inbound, picking, and pack-out processes across multiple product lines.
  
• Strong background in waving processes and shortage resolution, critical to ensuring on-time order fulfillment.
  
• Experience testing within Blue Yonder WMS environments, following documentation best practices to ensure system reliability and consistency.
  
• Skilled in troubleshooting support requests related to WMS and integrated systems or interfaces.
  
• Experience developing and maintaining SOPs and site-specific process documentation to ensure consistent and efficient operations.
  
• Familiarity with shipping quality guidelines, and extensive experience in inventory management and quality control to ensure operational excellence.
  

Supervision/Management of Others:

• 
  
• The position does not supervise other employees
  

Internal and External Contacts/Relationships

• 
  
• Internal: Warehouse and Logistics team, Getinge employees
  
• External: Working relationships with external vendors, operations, and IT team members
  

Environmental/Safety/Physical Work Conditions

• 
  
• Ensures environmental consciousness and safe practices are exhibited in decisions
  
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
  
• May work extended hours during peak business cycles
  

Permissions

Each organization shall establish the appropriate authority, and interrelation of all employees who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

At Getinge, we offer a comprehensive benefits package, which includes:
* Health, Dental, and Vision insurance benefits
* 401k plan with company match
* Paid Time Off
* Wellness initiative & Health Assistance Resources
* Life Insurance
* Short and Long Term Disability Benefits
* Health and Dependent Care Flexible Spending Accounts
* Commuter Benefits
* Parental and Caregiver Leave
* Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Who we are:

Atkore is forging a future where our employees, customers, suppliers, shareholders, and communities are building better together - a future focused on serving the customer and powering and protecting the world.

With a global network of manufacturing and distribution facilities worldwide, Atkore is a leading provider of electrical, safety and infrastructure solutions.

Who we are looking for:

We are currently looking for a BIM Technician to be based out of Tampa, FL reporting to the Drafting Manager. This person will be responsible for working with the project team to develop accurate and complete modeling drawing sets. The BIM Technician will ensure the integrity of project drawings while maintaining privileged information per the customer and company requirements.

What you'll do:

• 
  
• Accurately identify product specifications and understand of detail assemblies and their application for installation.
  
• Create or revise/update construction drawings, maintaining a tracking log of drawings.
  
• Review drawings for accuracy and scope of work, ensuring quality of final drawings.
  
• Collaborate with team and customers to ensure that projects are successfully completed, and best practices/technical issues are addressed.
  
• Run the multi trade coordination for clashes to assist project team with the design process.
  
• Conduct clash detection and visual walkthroughs using Navisworks Manage.
  
• Research ways to continuously improve our process including providing insight into new time saving methodologies and best practices.
  
• Manage, maintain, and update BIM Project documents.
  

What you'll bring:

• 
  
• Bachelor's (preferred) or Associates Degree in Architecture, Engineering, and Construction (AEC) related field with 1 to 3 years of industry experience.
  
• 1+ years' experience in 3D Revit or 3D AutoCAD.
  
• Technical certificates in Drafting and ED BIM Modeling training (preferred).
  
• Experience with Autodesk Revit, CAD, and BIM procedures (Preferred).
  
• Familiarity with Overhead coordination process including 3D Modeling utilizing Revit in project environment, Project As-builts and turnover for Facility management.
  
• Experience with Microsoft Office Suite, CAD and BIM systems including Autodesk AutoCAD, Revit Suite, BIM 360, Veo, Bluebeam, Word, Excel, and PowerPoint.
  

Within 3 months, you'll:

• 
  
• Complete the onboarding material and training on companies' products and drafting processes.
  
• Collecting information from multiple plans and incorporating them into a model which can be used to build structural support.
  
• Produce 2D shop drawings and 3D models projects with assistance of PM and BIM Designer.
  
• Complete Atkore Immersion process.
  

Within 6 months, you'll:

• 
  
• Communicate effectively with PM's and other team members in order to gather the information needed for each project.
  
• Develop strong knowledge of the companies' products and produce accurate designs based on each project needs.
  
• Assist with BIM Designer to coordination meeting and be part of BIM project development at different phases: modeling, cleaning clashes and producing shop drawings.
  

Within 12 months, you'll:

• 
  
• Produce structural models and drawings using Revit and manage coordination projects.
  
• Manipulate and develop CAD library components for AutoCAD and Revit or other related software.
  
• Independently handle BIM project from start to finish by assisting to BIM Coordination, performing clash detection, and resolving coordination issues.
  

Atkore is a recipient of a Great Place to Work certification and a Top Workplaces USA award! We're committed to creating an engaged and aligned workforce that drives collaborative culture. Our team strives for breakthrough results, stays focused on being standout leaders, and fully supports decisions of the Company. We consistently live the Atkore mission, strategic priorities, and behaviors, all in a way that's consistent with our core values. Together, we build strong leaders that continually endeavor to move us forward.

With a global network of manufacturing and distribution facilities worldwide, Atkore is a leading provider of electrical, safety and infrastructure solutions.

Join our team and align yourself with an industry leader!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Pay: $175K+ annually ($150K-$175K base + up to 20% performance bonus), and full benefits.

Location: Onsite 5 days (7a-4p) a week in Northern NJ

Client: Exceptionally successful national manufacturing brand

This is a confidential search for a hands-on Plant Manager to lead operations at:

A custom metal fabrication facility serving large-volume clients (very unique job shop with custom projects).

This facility specializes in sheet metal, tubing, and wire component fabrication, with capabilities including laser cutting, NC punching, brake forming, roll forming, TIG/MIG welding, spot welding, grinding, and in-house powder coating.

Job Summary

We are seeking a strategic, operationally strong manufacturing leader with deep experience in metal fabrication and a strong commitment to safety, quality, and continuous improvement. This role requires an accountable and results-driven professional who can lead teams, manage plant budgets, and drive operational efficiency in a fast-paced production environment.

The ideal candidate thrives on problem-solving, builds high-performing teams, and delivers operational excellence.

What You Will Do

• Direct and oversee daily plant operations including production, maintenance, quality control, inventory, and shipping/receiving
• Develop and implement strategies to improve productivity, reduce waste, optimize costs, and ensure on-time delivery
• Establish and monitor KPIs (scrap rates, downtime, safety metrics, throughput, etc.) and implement corrective actions
• Develop and manage plant budgets and capital expenditures
• Ensure compliance with federal, state, and local regulations including OSHA and workplace standards
• Drive Lean Manufacturing and continuous improvement initiatives
• Oversee preventive maintenance programs to ensure equipment reliability
• Lead, mentor, and develop management staff and production personnel
• Partner cross-functionally with Sales, Engineering, and Supply Chain to align plant performance with business goals
• Manage vendor and contractor relationships

What It Takes to Succeed

• Bachelor’s degree in Engineering, Manufacturing, Business, or related field (or equivalent experience)
• 7–10+ years of progressive leadership experience in manufacturing
• Strong experience in metal fabrication operations (machining, welding, forming, stamping, finishing)
• Demonstrated leadership and team development capability
• Knowledge of workplace safety and regulatory compliance

Preferred Experience

• Lean / Six Sigma certification
• ERP / MRP systems experience
• Experience in union environments (if applicable)

Work Environment

Manufacturing facility environment requiring regular presence on the production floor and adherence to PPE and safety standards.

About the Role

The candidate will support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission.

Responsibilities

• Support preparation and review of technical reports and QC documentation required for the BLA, ensuring timely completion and regulatory accuracy.
• Create, maintain, and monitor QC testing trackers, documenting tests, timelines, assigned analysts, sample workflows, and status updates.
• Facilitate and maintain a resource loading tracker, aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA.
• Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones.
• Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission.
• Lead the establishment and maintenance of a stability program, ensuring data availability for regulatory filing.
• Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Biology, required
• 5+ years of experience in an FDA-regulated pharmaceutical with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA).
• 5+ years of experience in analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation.
• Strong working knowledge of USP/EP, cGMP, EU GMP, and analytical compliance requirements.
• Proven experience tracking testing deliverables, coordinating QC schedules

Preferred Skills

• Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments.
• Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.

Change Control Technical Writer

The CC Tech Writer will ensure compliance by coordinating Change Controls associated with supplier and raw materials changes to primary and secondary packaging, API’s, and excipients impacting company internal and external sites. The CC Tech Writer will initiate EtQ system CC requests to be communicated to internal and external manufacturing, testing and packaging sites with input from Sourcing, Supplier Quality, Site Leaders, Quality, and other Subject Matter Experts (SMEs) as needed. The CC Tech Writer will present CC Requests at Change Control Committee (CCC) Meetings and interface with the CC approvers to align CC wording, requirements and deliverables as needed to facilitate approval process.

As part of this role, the CC Tech Writer will track/monitor CCs through their lifecycle. This includes, but is not limited to timely promotion & notification of change in status, regular updates to CC owners (Sourcing, Site Leaders, Quality & SMEs) on CCs and deliverable status, weekly monitoring and reporting of change control metrics including submissions, approvals and closures. This role will coordinate deliverables execution and documentation in CC as deliverables are received and ensure CCs are closed in a timely manner or initiate extensions when necessary if target closure date is not attainable. In some cases, the CC Tech Writer will need to act as a project manager and facilitate team meetings to ensure that changes are implemented to meet business needs.

Qualifications

A Bachelor's Degree is required. A focus degree in Science or Engineering Technologies is preferred. A minimum of 4 years experience in a GMP regulated environment (pharmaceutical etc.) is required. A technical writing background is preferred. Experience with pharmaceutical or consumer manufacturing (processing/packaging, etc.) is required. Experience with facilities, validation, analytical sciences, microbiology or engineering is preferred.

The ability to handle multiple, at times complex change controls at one time is required. The ability to read, analyze and interpret common scientific and technical documents is required. Project management, organizational skills and the ability to adapt to a fast-paced environment with changing priorities is preferred. The ability to effectively present information and communicate clearly to all levels of management is required. The ability to work directly with internal and external manufacturing sites under limited supervision is preferred. Knowledge of computer systems and proficiency with Microsoft Office Suite of programs (Word and Excel is required, Visio, Project, PowerPoint, and Access skills are preferred). Previous experience working in cross functional matrix environment with an ability to influence without authority is required. Knowledge of six sigma, process improvement or lean is preferred. Individual must demonstrate the following: detail and goal oriented, work in a team environment, customer-focus, ability to manage multiple projects, prioritize and adapt to business needs, have a thorough understanding of compliance requirements, effective verbal and written communication skills, interdependent partnering, strong decision-making/analysis skills, problem-solving and Lean mindset.

Global Product Quality Specialist

12-month Contract

Remote- EST Hours

Responsibilities:

• Quality Systems Support:
• Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.
• Support of regulatory submissions, annual reports and preparation of annual product quality reviews
• Inspection readiness for Internal and external audits
• Compile metrics for continuous improvement initiatives
• Assist in the writing of Quality Agreements
• Documentation Review:
• Review of API, DP and Packaging batch records
• Review of test methods, component specifications, validation protocols/reports, BOM
• Review of stability protocols and reports, and data in LIMS
• Operational QA Support:
• Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentation
• Creates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)
• Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSign
• Project QA Support:
• Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently met
• Ensure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supply

Qualifications:

• BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment
• 4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development function
• Ability to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)
• Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principles
• Working knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processes
• Experience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)
• Strong written and verbal communication skills; ability to collaborate with cross-functional teams
• Proficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).
• Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.