Engineering Jobs in Plainsboro
33 positions found — Page 2
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 Director, Quality Systems is a hands-on leadership role responsible for leading the development, design, and maintenance of the Quality Management System (QMS). This role will oversee the implementation and continuous improvement of the QMS to maximize efficiency, effectiveness, and compliance with all applicable GxP regulations and client requirements and expectations.
Key Responsibilities
• Develop and maintain the Site Quality Management System and provide ongoing assessment of QMS effectiveness through Quality Management Review (QMR) and other established monitoring programs and processes.
• Identify, execute, and manage quality improvement initiatives to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations and client requirements.
• Support the development of company objectives and ensure Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.
• Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics.
• Identify compliance gaps and improvement opportunities to inform the Site Quality Plan and inspection readiness strategies.
• Co-lead the Internal Audit program with the Head of Inspection Readiness, including oversight of audit schedules and ensuring appropriate follow-up in alignment with internal procedures, regulatory expectations, client requirements, and auditing best practices.
• Manage the CAPA system, ensuring root causes are clearly identified and addressed through robust corrective actions to prevent recurrence, and that actions are evaluated for effectiveness post-implementation.
• Establish and manage GMP training programs to ensure training requirements align with job functions and job descriptions.
• Collaborate with the Head of Inspection Readiness to coordinate activities related to regulatory and client inspections (announced or unannounced), including preparing documentation, identifying potential compliance gaps, and managing inspection logistics.
• Support post-inspection response activities, including drafting responses, coordinating updates, and ensuring follow-up actions are implemented within the QMS.
• Provide input into regulatory inspection responses to ensure systemic and comprehensive solutions address root causes and prevent recurrence.
Leadership & People Management
• Mentor and coach team members to continually develop and enhance their skills.
• Lead by demonstrating the company values of standing shoulder to shoulder, owning it always, breakthrough thinking, and competing where it counts.
• Foster a culture of accountability with progressive empowerment and ownership.
• Promote a culture that values innovation, continuous improvement, and personal accountability across the organization.
Required Qualifications
• Bachelor’s degree in Biology, Chemistry, Engineering, or a related scientific discipline.
• 10–12 years of cGMP or Quality experience, including prior supervisory or team leadership experience; or a Master’s degree with 5–7 years of relevant experience.
• Experience hosting and managing regulatory and client inspections.
• Strong understanding of Quality Systems requirements and regulatory expectations.
• Excellent oral and written communication, listening, and problem-solving skills.
• In-depth knowledge of regulated activities, health authority expectations, GxP, and Quality Risk Management.
• Strong organizational awareness with significant experience working cross-functionally.
• Experience developing and executing large-scale organizational change initiatives, including change management strategies and planning.
• Demonstrated ability to understand complex processes and facilitate teams toward effective solutions.
• Ability to design and implement global business processes and policies with a strategic and enterprise mindset.
• Proven experience influencing stakeholders across a broad spectrum of GxP topics.
• Flexibility to support varying work schedules, including evenings, weekends, or holidays as needed.
Preferred Qualifications
• In-depth knowledge of cGMP regulations and the ability to apply them in compliance with U.S., EU, and global regulatory standards.
• Experience with cell and gene therapy manufacturing in clinical or commercial environments.
• Strong track record managing quality systems and training programs.
• Expertise in aseptic manufacturing processes.
• Demonstrated ability to foster collaboration, influence cross-functional teams, and drive cultural and operational improvements.
• Innovative mindset with the ability to adapt best practices within a fast-paced, growing organization.
Required Degree
• B.S. in a relevant scientific discipline (advanced degree preferred).
Physical Requirements
Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for aseptic processing facilities, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals.
Company Description
CCL Industries is a global leader in specialty packaging & Labeling solutions, offering a wide range of innovative products. These include extruded and laminated plastic tubes, folded instructional leaflets, and precision-printed components with LED displays, among others. CCL also operates Avery, the world's largest supplier of labels, specialty media, and software for short-run digital printing. Additionally, the company includes CCL Container, a top producer of aluminum aerosol cans and bottles for consumer packaged goods in the United States. With its diversified product portfolio, CCL serves a variety of end-use markets worldwide.
Role Description
This is a full-time on-site role for a Production Supervisor - Labeling & Packaging, based in Hightstown, NJ. The Production Supervisor will oversee and coordinate labeling and packaging operations to ensure efficient workflows. Responsibilities include managing production schedules, overseeing production planning, and ensuring quality standards are consistently met. The role involves directing and supporting production staff, addressing any operational issues, and adhering to safety protocols within the facility.
Essential Functions
- Oversees daily production operations to ensure scheduled jobs are completed safely, accurately, and on time.
- Leads, trains, and supports production staff, promoting teamwork, efficiency, and adherence to company policies.
- Monitors production equipment and workflows to maintain quality standards and minimize downtime.
- Ensures compliance with safety regulations, cGMP, and operational procedures at all times.
- Coordinates material needs, machine setups, and job changeovers to maintain continuous production flow.
- Troubleshoots production issues and implements corrective actions to improve performance and reduce waste.
- Tracks and reports production metrics, including output, quality, waste, and labor utilization.
- Communicates effectively with leadership, quality, logistics, and other departments to support overall plant operations.
- Supports continuous improvement initiatives, including Lean, 5S, and process optimization efforts.
Qualifications
- Flexographic printing experience is strongly preferred for this role.
- Strong Supervisory Skills, including team leadership and employee development
- Experience in Production Planning and Production Schedules to manage efficient workflows
- Competency in Production Management practices to ensure operational efficiency and quality
- Excellent Communication skills, including the ability to provide clear direction and foster collaboration
- Knowledge of safety procedures and guidelines in a packaging or manufacturing environment
- Problem-solving and organizational skills to manage multiple priorities effectively
- Previous experience in labeling or packaging industries is a plus
- Associate or Bachelor’s degree in Engineering, Management, or a related field is preferred
Skills/Aptitudes:
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
- Ability to write routine reports and correspondence.
- Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.
- Skill in operating computer systems with a proficiency in Word/Excel and ability to learn AS400.
- Ability to speak effectively and present information in one-on-one and small group situations to customers, vendors, and other employees of the organization.
- Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists.
Compensation: $80,000 – $93,000 per year
Schedule: Monday-Friday: 2nd shift (3:00pm-11:00pm) or 3rd shift (11:00pm-7:00am)
Working Conditions/Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and ink vapors. The noise level is usually loud.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects or operate pressroom equipment and tools, reach with hands and arms, talk and hear, and lift at least 50 lbs.
Specific vision abilities required by this job include close vision, distance vision, color-vision, peripheral vision, depth perception, and ability to adjust focus.
Title: Contracts Compliance Manager
Pay: $130,000 – $160,000 base + bonus potential
Location: Hamilton Township, NJ | Fully onsite with up to 25% travel (primarily to east coast HQ and field offices)
Company: Confidential manufacturing subsidiary of a publicly traded clean energy company
About the Role
A newly created, high-visibility opportunity for an experienced Contracts Compliance Manager to lead contract negotiation, administration, and compliance for both commercial and government sectors. This role supports a fast-growing manufacturing site and works cross-functionally with leadership, engineering, finance, and sales to manage contract risk, ensure FAR/DFARS compliance, and support real-time business decisions.
Responsibilities
Contract Management & Negotiation
- Draft, review, and negotiate a wide range of contracts (government, commercial, subcontracts, NDAs, POs, and MSAs).
- Oversee cradle-to-grave contract administration and ensure timely fulfillment of obligations.
- Lead contract negotiations with customers and vendors, balancing business goals with risk mitigation.
- Review RFPs/RFQs to ensure compliance and recommend appropriate risk management terms.
Compliance & Risk Oversight
- Ensure full compliance with FAR/DFARS and other government contracting requirements.
- Maintain alignment with public-company policies and standards.
- Partner with internal teams on audits, reporting, and documentation accuracy.
- Provide training and guidance to stakeholders on contract and compliance requirements.
Cross-Functional Collaboration
- Work closely with the General Manager, Engineering, Sales, and Finance teams.
- Support process improvements, revenue recognition, and operational efficiency initiatives.
- Serve as a subject matter expert on all contract compliance and policy interpretation.
Requirements
- Bachelor’s degree in Business, Legal Studies, Government Contracting, or related field (JD preferred).
- Minimum 5+ years managing both commercial and government contracts in manufacturing, defense, or industrial environments.
- Proven success in managing contracts cradle-to-grave and navigating FAR/DFARS.
- Product-based contract experience required (not software/IP).
- Strong drafting, negotiation, and analytical skills.
- Excellent communication and relationship management abilities.
- Experience with compliance initiatives or process improvement preferred.
Preferred Attributes
- Hands-on, adaptable team player with a proactive mindset.
- Strong business judgment and ability to work independently.
- Comfortable in a fast-paced, evolving environment.
- Sense of humor, accountability, and collaborative spirit highly valued.
Culture & Growth
- Tight-knit, collaborative team where everyone “rolls up their sleeves.”
- Exposure to senior leadership and opportunities to shape policies and processes.
- Onsite culture that values initiative, learning, and cross-functional visibility.
- Long-term stability with the backing of a publicly traded clean energy leader.
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.
Branch Manager:
On behalf of our client, Procom is searching for a Branch Manager for a permanent role. This position is onsite at our client’s Hamilton Township, New Jersey office.
Branch Manager - Job Description:
Seeking a Branch Manager to lead and grow our Hamilton, NJ branch. The role involves overseeing branch operations, promoting our quality reputation, and driving focused growth, while fostering positive interdepartmental relationships and ensuring compliance with company policies.
Branch Manager - Responsibilities:
• Foster positive relationships across departments including Field Operations, Sales, Manufacturing Operations, Finance, Engineering, etc.
• Resolve conflicts within the branch and escalate issues when necessary to Regional Manager and Human Resources
• Adhere to business code of conduct guidelines and act as a model/mentor to associates in your branch
• Monitor and adhere to Sarbanes Oxley (SOX) requirements and procedures
• Oversee and direct the activities/operations for all branch personnel
• Manage all employee performance planning/reporting, OSHA logs, payroll processing, and expense reports
• Conduct hiring, discipline, and termination of personnel
• Ensure branch personnel receive required training and oversee EH&S Web-based training
• Coordinate the purchase and disposal of all Fleet vehicles with Fleet Services
• Manage and drive productivity projects to completion while maintaining project timelines and established budget
• Oversee all fixed and recurring costs in the branch and manage Branch P&L
• Conduct site visits with technicians and customers
Branch Manager - Mandatory Skills:
• Bachelor’s Degree preferred, HS required
• 5+ years of experience in management of people
• 5+ years of experience owning a P&L
• 5+ years of experience in a Construction/Service business
• Ability to work in a fast-paced environment and manage multiple initiatives concurrently
• Creative problem-solving abilities with a strong passion for driving process improvements and results
• Excellent communication skills with ability to grasp technical aspects of products and programs
Branch Manager – Nice-to-Have Skills:
• Experience with Microsoft Dynamics365
• Experience with Astea
• Experience with SmartSheet
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
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)
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.