Engineering Structures Impact Factor Jobs in Dayton, NJ
161 positions found — Page 9
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 Inspection Readiness Lead (Associate Director) is a quality leader responsible for establishing, maintaining, and continuously improving a state of inspection readiness across GMP cell therapy operations, spanning clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual partners closely with the Site Quality & GMP Compliance Lead and key cross-functional stakeholders to ensure GMP alignment, consistent execution, and inspection readiness across regulatory interactions.
Key Responsibilities
Inspection Readiness & Regulatory Compliance
• Design, implement, and sustain an inspection readiness program supporting clinical and commercial cell therapy manufacturing.
• Maintain a continuous state of readiness for FDA, EMA, and other global health authority inspections, as well as client audits.
• Ensure alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP (Annex 1 & 2), ICH guidelines, and global regulatory expectations for advanced therapies.
• Collaborate with Regulatory Affairs and the PMO to translate evolving regulatory and client expectations into actionable inspection readiness strategies, standards, and best practices.
Regulatory Inspections, Client Audits & Customer Assessments
• Serve as the front-room inspection lead for regulatory authority inspections and client audits.
• Lead and coordinate inspection and audit readiness activities, including mock inspections, readiness assessments, gap analyses, and SME coaching.
• Coordinate execution of inspections and audits, including inspection teams, war room operations, daily briefings, issue tracking, and executive updates.
• Lead the development and execution of inspection and audit responses, including FDA 483 observations, regulatory commitments, and client responses, ensuring consistency.
Quality Systems Interface & Continuous Improvement
• Partner with Quality Systems, Site Quality, and Technical Operations teams to ensure audit-ready performance.
• Analyze inspection and audit trends to identify systemic compliance risks and drive remediation and continuous improvement.
• Support inspection readiness for new site start-ups, facility expansions, technology transfers, and commercial launches.
Leadership, Influence & Collaboration
• Provide functional leadership and mentoring on inspection readiness to SMEs and site quality partners, fostering a culture of proactive compliance and inspection confidence.
• Align and influence stakeholders across Quality, Technical Operations, MSAT, Regulatory Affairs, and Program Management to drive inspection readiness initiatives.
• Serve as a trusted advisor to senior leadership on inspection risk, regulatory exposure, and readiness status.
• Champion a strong culture of quality and compliance, reinforcing consistent behaviors, decision-making, and regulatory interactions during audits and inspections.
Required Qualifications
• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
• 10+ years of progressive quality leadership experience in cell therapy, biotech, or biologics, with deep exposure to GMP operations.
• Strong expertise in cell therapy or ATMP manufacturing and in-depth knowledge of global GMP regulations (FDA, EMA, ICH, ROW).
• Proven track record in a CDMO environment managing multiple client programs and regulatory compliance requirements.
• Demonstrated leadership during regulatory inspections, including FDA inspections and 483 resolution.
• Excellent verbal and written communication skills, with the ability to articulate complex compliance topics to inspectors, clients, and executive leadership.
• Experience leading audit and inspection planning, execution, and response activities.
• Willingness to work flexible hours, including evenings, weekends, and shift-based schedules as needed.
• Strong organizational skills with the ability to prioritize and manage multiple demands while maintaining a solution-oriented mindset.
Preferred Qualifications
• Experience supporting multiple clients simultaneously within a CDMO.
• Direct experience with pre-approval inspections (PAIs), BLA/MAA readiness, or commercial launch inspections.
• Experience supporting rapid-growth organizations, new site start-ups, or late-stage to commercial transitions.
• Lean, Six Sigma, or quality excellence certifications.
Educational Requirement
• B.S. in Life Sciences, Engineering, or related discipline required; advanced degree preferred.
Physical Requirements
• Ability to perform essential job functions in compliance with company standards, including productivity and attendance.
• Willingness to work in various controlled environments, including CNC/ISO7–8 cleanrooms.
• Ability to lift up to 25 lbs and perform physical tasks such as bending, standing, and working with cell-based products or chemicals.
• Must be flexible and adaptable to changing priorities and dynamic environments.
SUMMARY/OBJECTIVE:
The Senior Director, Operations is responsible for leading day-to-day operational execution across manufacturing, packaging, project management, facilities, and warehouse functions within a cGMP, CDMO, or CMO environment. This role translates company strategy into operational plans, drives performance against key metrics, and ensures safe, compliant, and efficient delivery of client programs. The Senior Director partners closely with Quality, Research & Development, Operations, Logistics, Finance and Business Development to support growth, client satisfaction, and inspection readiness.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide operational leadership and oversight for both U.S. and Ireland-based operations teams, ensuring alignment of processes, priorities, and performance expectations across sites.
- Lead daily operations across manufacturing and packaging services, ensuring schedule adherence, quality, and throughput.
- Own operational performance metrics (e.g., OTIF, right-first-time, labor utilization, cost control, and equipment performance).
- Translate strategic objectives from executive leadership into executable operational plans and priorities.
- Provide leadership and development for operations managers and cross-functional teams.
- Partner with Project Management to align production schedules with client timelines and contractual commitments.
- Ensure compliance with cGMP, FDA, DEA (as applicable), and company quality systems; support internal and external audits.
- Drive continuous improvement and operational excellence initiatives, including lean practices and waste reduction.
- Collaborate with Quality on deviation investigations, CAPAs, and risk mitigation actions.
- Support client onboarding, tech transfer, and scale-up activities to ensure successful execution.
- Work with Facilities and Engineering to optimize equipment utilization, maintenance planning, and capacity expansion.
- Collaborate with Warehouse teams to ensure material availability and inventory accuracy.
- Provide operational input during new business assessments and client proposals.
- Maintain effective communication with senior leadership on performance, risks, and resource needs.
- Comply with all company and site policies and procedures and perform other duties as assigned
QUALIFICATIONS AND EXPERIENCE:
- Bachelor’s degree required (Engineering, Life Sciences, or related field preferred).
- 8–12+ years of experience in cGMP pharmaceutical manufacturing and/or packaging environments, including at least 5 years supporting clinical and commercial manufacturing and packaging operations.
- 5+ years of progressive leadership experience managing operations teams.
- Experience in a CDMO/CMO or multi-client manufacturing environment required.
- Demonstrated success leading regulatory inspections and client audits.
- Strong understanding of pharmaceutical packaging, production planning, and operational controls.
COMPETENCIES/SKILLS:
- Strong operational leadership and execution mindset.
- Excellent analytical, problem-solving, and decision-making skills.
- Ability to interpret data and drive performance improvements.
- Effective communication and stakeholder management skills.
- Financial acumen with experience managing budgets and operational costs.
- Ability to lead cross-functional teams in a fast-paced CDMO environment.
- High integrity, professionalism, and accountability
SUPERVISORY RESPONSIBILITIES:
Yes. Typically includes Production/Packaging Managers, Warehouse leadership, Facilities leadership, Project Management and other operations personnel as assigned.
WORK ENVIRONMENT:
Hybrid office and manufacturing environment; routine presence on the production floor required.
SCHEDULE:
On-site 5 days per week in Cranbury, NJ office
SALARY:
$190,000 - $240,000
PHYSICAL DEMANDS:
Combination of office-based work and time in warehouse/manufacturing areas. Ability to stand, walk, and move through production areas as needed.
TRAVEL:
Up to 20–30% travel may be required based on client and business needs.
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.
Java / Software Developer Opportunity @ BeaconFire
Location: East Windsor New Jersey
Visa Sponsorship Available | E-Verified Company
Kickstart Your Career with BeaconFire!
Are you passionate about coding and looking to grow your career in Software Development?
BeaconFire, based in Central NJ, is a leader in Software Development, Web Development, and Business Intelligence. We're on the lookout for dynamic individuals with a strong background in Software Engineering or Computer Science to join our team as Java / Software Developers!
What You'll Be Doing:
- Develop applications using Java 8/JEE (and higher), Angular 2+, React.js, SQL, Spring, HTML5, CSS, JavaScript, TypeScript, and more.
- Write scalable, secure, and maintainable code for high-impact client platforms.
- Create, deploy, and maintain automated system tests.
- Collaborate with testers to understand and resolve defects efficiently.
- Investigate new technologies and tools for continuous improvement and architecture reviews.
- Work closely with team members to achieve shared user story and sprint goals.
What We're Looking For:
- Experience in Java and JavaScript programming languages.
- A good understanding of the Software Development Life Cycle (SDLC).
- Strong object-oriented programming (OOP) skills and knowledge of Collections, Maps, Lists, Sets, and common APIs.
- Familiarity with relational databases like SQL Server or Oracle and basic SQL queries.
Preferred Qualifications:
- Master's Degree in Computer Science (CS).
- 0–1 year of hands-on experience in Java coding.
- Experience with Spring, Maven, Angular, HTML, and CSS.
- Knowledge of modern Java technologies like WebLogic, RabbitMQ, Tomcat.
- Familiarity with JSP, J2EE, and JDBC.
Why Join BeaconFire?
- E-Verified Employer
- Visa Sponsorship Provided
- Opportunities to work on cutting-edge tech
- Collaborative and growth-focused work culture
Apply Today and Build Your Future with BeaconFire!
Let's turn your passion into a profession!
- Effectively multitask and adapt to the dynamic demands of the role, ensuring timely and efficient service
- Exceed customer expectations through ease, empathy and encouragement, delivering results related to individual and branch goals
- Develop new connections and maintain ones by engaging customers throughout the loan process and life cycle, presenting tailored solutions based on customer needs
- Manage the life cycle of loans, including collections activities while maintaining compliance with all relevant laws and regulations
- Engage with customers and other departments through multiple technological channels, including phone, email, chat and our in-house systems
- Exhibit passion for achievement, bringing an internal drive to succeed and goal oriented attitude
- Clearly educate and inform customers on optional insurance products, ensuring customers have a thorough understanding of the loans, terms and their options
- High School Diploma or GED?????
- Sales, Collections or Customer Service experience???
- Bilingual - Spanish???
- Health and wellbeing options including medical, prescription, dental, vision, hearing, accident, hospital indemnity, and life insurances
- Up to 4% matching 401(k)
- Employee Stock Purchase Plan (10% share discount)
- Tuition reimbursement
- Paid time off (15 days’ vacation per year, prorated based on start date)
- Paid sick leave as determined by state or local ordinance (prorated based on start date)
- 11 Paid holidays (4 floating holidays, prorated based on start date)
- Paid volunteer time (3 days per year, prorated based on start date)
- Effectively multitask and adapt to the dynamic demands of the role, ensuring timely and efficient service
- Exceed customer expectations through ease, empathy and encouragement, delivering results related to individual and branch goals
- Develop new connections and maintain ones by engaging customers throughout the loan process and life cycle, presenting tailored solutions based on customer needs
- Manage the life cycle of loans, including collections activities while maintaining compliance with all relevant laws and regulations
- Engage with customers and other departments through multiple technological channels, including phone, email, chat and our in-house systems
- Exhibit passion for achievement, bringing an internal drive to succeed and goal oriented attitude
- Clearly educate and inform customers on optional insurance products, ensuring customers have a thorough understanding of the loans, terms and their options
- High School Diploma or GED?????
- Sales, Collections or Customer Service experience???
- Bilingual - Spanish???
- Health and wellbeing options including medical, prescription, dental, vision, hearing, accident, hospital indemnity, and life insurances
- Up to 4% matching 401(k)
- Employee Stock Purchase Plan (10% share discount)
- Tuition reimbursement
- Paid time off (15 days’ vacation per year, prorated based on start date)
- Paid sick leave as determined by state or local ordinance (prorated based on start date)
- 11 Paid holidays (4 floating holidays, prorated based on start date)
- Paid volunteer time (3 days per year, prorated based on start date)
About PSI: For over (30) years, Precision Surgical Inc. has been working with healthcare providers of all shapes and sizes. PSI is a network of trained professionals who collaborate to satisfy the clinical needs of healthcare partners by distributing quality medical products, providing service solutions, as we work to improve patient outcomes and prepare for the future
Are you looking for a new opportunity where you can make an impact working on dynamic projects with some of the largest healthcare networks in the region? Are you looking for an employer that values their staff and offers an environment for you to learn, grow, and thrive?
PSI is growing! We are looking to add team members to our rapidly expanding firm to allow us to better serve our healthcare clients.
Position: Medical Equipment/Device Sales Representative (Associate) - New Jersey
Responsibilities:
- Work closely with Senior Account Executives to support client needs
- Communicate to both new and existing clients the value and breadth of product available in the PSI
- product/service portfolio
- Assist in driving revenue and customer satisfaction through the territory
- Align with local manufacturer representatives to stay current on product offerings
- Attend local industry specific events and meetings
- Clearly communicate the value to both new and existing clients of working with PSI
Key Success Factors:
- Self-motivated and goal oriented
- Ability to work independently
- Organized with strong attention to detail
- Superior communication and presentation skills
- Strong work ethic
- Problem-solving skills and adaptable to change
- Desire to advance and progress in your career
Requirements:
- Bachelor’s degree or high school diploma with (2) years of relevant work experience
- (2) years of experience in sales and/or account management with documented success
- Medical/Healthcare/Acute Care experience preferred but not required
- Proficient with Microsoft Office Suite (Outlook, Word, Excel, etc.)
- Excellent communication and interpersonal skills
- Currently living in geographical location of the position
- Daily travel to regional office and/or client sites
Compensation & Benefits:
- Competitive Salary + Commission + Bonus
- Uncapped earning potential
- Paid Time Off (PTO) Program
- Company Laptop and Cell Phone
- Monthly Expense Allowance
- Auto Allowance
- Medical, Dental, & Vision Benefits
- 401K Retirement Plan with Employer Match
Precision Surgical Inc. is an equal opportunity employer. We welcome applications from all backgrounds regardless of race, color, religion, sex, national origin, ancestry, age, marital status, sexual orientation, gender identity, veteran status, disability, or any other classification protected by law.
We offer competitive pay, training and growth opportunities and a positive work environment.
Main Duties & Responsibilities: Follow proper testing & diagnostic procedures to accurately solve vehicle issues Maintain a clean, safe working environment Perform basic auto care and maintenance tasks such as oil changes, fluid level checks, and tire rotation Perform emissions inspections, safety checks and similar state-regulated vehicle examinations Test the functionality of parts and systems Repair brake and steering systems Diagnose and repair electrical and electronic systems Replace or repair transmissions and fuel components as needed Repair cooling components and systems including air conditioners and engine cooling Complete tire changing, balancing, and installation Prepared to get additional certification as needed Willingness to learn with hands-on training Communicate effectively with Service Advisor about vehicle status and required parts and labor Explain automotive repairs and issues to non-technical employees and customers as needed Uphold the culture and values of our independently owned shop.
Qualifications: Possess a valid state driver’s license for conducting test drives High school diploma or equivalent education, advanced technical education preferred Possession of or ability to obtain ASE certification Strong written and verbal communication skills Analytical skills Coordination and physical stamina When you join the team at your local, independently owned TechNet Professional Service Center, you’ll be working with a shop that takes pride in what they do.
A local shop in your community, backed by the support of a Nationwide network.
That is just part of what sets a TechNet Automotive Service Center apart from the rest.
Come join #TechNetNation!
We are a diverse, passionate team spread across the US, Canada, Mexico, and Puerto Rico, committed to growth, learning, and creating opportunities for each other.
At Turtle, every day is a chance to make a real difference, solve complex challenges, and push the boundaries of what’s possible.
We believe in fostering an environment that inspires collaboration and sparks creativity, where employees are empowered to contribute to our mission and shape the future of the industry.
If you're looking for a fast-paced, dynamic career where your ideas are valued and your growth is prioritized, Turtle is the place for you.
Join us and be a part of a company that’s making waves and empowering its people to do extraordinary things every single day! About the Role The Will Call Supervisor oversees daily will call and expedited order operations, ensuring orders are processed accurately, efficiently, and on schedule.
Responsibilities include completing all will call orders, capturing proof of delivery (POD) documentation, and coordinating expedited requests such as Turtle Express and courier pickups.
Additionally, this position manages the returns team and assists the AM Warehouse Supervisor and Manager in morning warehouse operations, maintaining a safe and organized work environment, enforcing safety policies, and supporting warehouse productivity.
Supervisors are cross trained in multiple operational areas and may provide coverage as needed to ensure efficient daily operations.
What You'll Do: Ensure all employees have required PPE and perform tasks safely.
Oversee daily will call operations (order picking, staging, and completion).
Properly capture and record will call proof of delivery (POD) documentation.
Coordinate expedited order requests (Turtle Express, courier pickups, priority orders).
Accurately receive all PO pickups into the system in a timely manner.
Sort relay orders to appropriate delivery routes and ensure paperwork is given to dispatch.
Supervise returns team to process returns accurately and promptly.
Support AM warehouse functions: replenishments, receipts, transfers, and putaways.
Inspect forklifts and powered industrial equipment before each shift.
Conduct toolbox and safety meetings with will call and returns teams as needed.
Complete daily operational checklists and document all will call and return activities.
Learn and enforce company agreements and working rules.
Complete near miss and/or accident reports as required.
Conduct or oversee new hire training in will call and returns areas.
Work with Quality and Safety Manager on training targets, including ADP requirements.
Coach employees to prevent repeated errors and improve performance.
Assist with warehouse labor as needed (picking, packing, other tasks).
Be cross-trained and provide coverage in multiple operational areas to ensure smooth daily distribution center operations.
What You'll Bring High school diploma or equivalent required.
Minimum of 3–5 years of warehouse or distribution center experience.
Previous experience in a lead, coordinator, or supervisory role preferred.
Strong understanding of warehouse operations including will call, receiving, returns, and order fulfillment processes.
Experience working with warehouse management systems (WMS), RF scanners, and inventory systems.
Ability to prioritize multiple tasks and manage expedited and time-sensitive orders.
Strong communication and leadership skills with the ability to coach and guide team members.
Working knowledge of warehouse safety standards and OSHA guidelines.
Ability to operate or become certified to operate forklifts and other powered industrial equipment.
Ability to lift 50 lbs.
and work in a fast-paced warehouse environment.
Proficiency with basic computer systems and Microsoft Office applications.
What We Offer We offer a competitive benefits package that includes: 401(k) plan Health insurance Dental insurance Vision insurance Life insurance Paid holidays Vacation Employee negotiated discounts Who We Are Founded in 1923, Turtle is a fourth-generation, family-owned, and three-generation women-owned business, and one of the nation’s largest independent electrical and industrial distributors.
Headquartered in Clark, NJ, our Electrical Distribution division operates 14 branches spanning from coast to coast.
It is a significant force in the engineering and procurement of power distribution, automation, lighting, and energy projects, offering integrated services for the industrial and construction markets.
Turtle Integrated provides on-site MRO procurement, cost-saving, and spend analytics across the US and in Canada, Puerto Rico, and Mexico.
What To Do Next You can begin by filling out our application online.
If you want to learn more about Turtle, please visit our website or our LinkedIn: @Turtle.
Turtle is proud to be is an equal opportunity employer that is committed to diversity and inclusion in the workplace.
We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity or expression, national origin, disability, genetic information, pregnancy, marital status, military or veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
Job Title: Survey CAD Technician
Location: Edison, NJ (In-Office)
Position Overview
We are seeking a detail-oriented and experienced Survey CAD Technician to join Clients team in Edison, NJ. The ideal candidate will have strong proficiency in AutoCAD Civil 3D within a surveying and/or construction environment and a solid technical background. This role requires the ability to collaborate effectively with engineers, designers, survey technicians, and project managers to produce high-quality survey drawings and plans that meet company and industry standards.
What We Offer
- Competitive compensation based on experience.
- Opportunity to work on diverse and challenging survey projects.
- Collaborative team environment.
- Professional growth and development opportunities.
Requirements:
- Must be able to commute to office in Edison, NJ.
- Must have experience using AutoCAD Civil 3D in a surveying and/or construction environment.
Essential Functions & Responsibilities
- Plan and prepare preliminary layouts and detailed design drawings from engineering notes, sketches, and other reference materials, ensuring compliance with company standards and applicable codes.
- Prepare ALTA/NSPS Land Title Surveys, Boundary Surveys, Topographic Surveys, Location Surveys, Utility Surveys, Roadway Topographic Surveys, Subdivision/Lot Consolidation Plans, and As-Built Surveys.
- Perform calculations of survey points for construction layout purposes.
- Prepare construction cut sheets.
- Create survey plans from field crew data collector files (points), field sketches, digital photographs, and reference maps.
- Generate surfaces using 3D polylines and point data within Civil 3D.
- Research and obtain applicable standards and codes required by clients, municipalities, and counties through coordination with project managers, survey technicians, and administrative staff.
- Coordinate project requirements with team members and assist in completing required tasks to meet deadlines.
- Work closely with Engineers, Designers, and other Drafters to ensure coordinated design efforts are maintained.
- Utilize third-party applications to generate drawings based on specific project requirements.
- Process lidar scan data (preferred but not required).
- Prioritize and manage multiple projects while adhering to CAD standards and deadlines on a daily basis.
Qualifications:
- Proficiency in AutoCAD Civil 3D (required).
- Experience in a surveying and/or construction environment (required).
- Knowledge of lidar scan data processing (a plus).
- Proficiency in Microsoft Word and Excel.
- Strong technical background with attention to detail.
- Excellent organizational, communication, and time-management skills.
- Ability to multi-task and meet project deadlines.
- Team-oriented mindset with a collaborative approach to work.
If you are a motivated CAD professional with a strong background in surveying and a commitment to quality and accuracy, we encourage you to apply.
