Engineering Jobs in Pennington, NJ

Join a mission-driven environmental and engineering consulting firm that has been delivering innovative water resources and ecological restoration solutions. This Geotechnical Engineer / Technical Project Manager (PE Required) opportunity is based in Trenton or Sicklerville, NJ and offers the chance to work on meaningful projects such as stormwater management systems, dam removals, wetland restoration, coastal protection, and floodplain reconnections. If you’re passionate about sustainable infrastructure and want to collaborate with a team that values environmental stewardship, creativity, and a positive work culture, this is an exciting place to grow your career.

Qualifications and responsibilities for this Geotechnical Engineer / Technical Project Manager position include:

• Bachelor’s degree in Civil Engineering – Plan and execute subsurface investigations for land and water-based projects
• Professional Engineer (PE) license required – Perform geotechnical analyses including slope stability, seepage, bearing capacity, settlement, and liquefaction
• 6+ years of geotechnical engineering experience – Lead and manage geotechnical aspects of ecological restoration and water resources projects
• Experience with foundation and earth structure design – Analyze axial and lateral capacities of deep foundations and sheet pile systems
• Proficiency in AutoCAD and Civil 3D – Prepare geotechnical reports, drawings, and technical plans
• Strong written and verbal communication skills – Prepare proposals, technical reports, and present findings to clients and stakeholders
• Project management and time management skills – Oversee multiple projects including scheduling, coordination, and client interaction
• Leadership and mentoring ability – Train junior staff and provide geotechnical guidance across multiple practice areas

Salary: $95,000 - $125,000 per year, commensurate with experience.

Benefits: This full-time, permanent, direct-hire position offers great benefits including medical, dental, and vision insurance; a 401(k) plan with a 5% company match after three months and immediate vesting; paid vacation and personal time off; paid parental leave; and a hybrid work schedule with flexible core hours.

DAVRON is the leading Headhunter and Executive Search firm for Engineering, Architecture, Construction and Manufacturing professionals nationwide. Our recruiters have direct communication with hiring managers allowing us to get you in front of company decision makers. You also receive one-on-one interview preparation and insider coaching from staffing experts to help you every step of the way. We want to see you thrive in challenging work environments that bring you excitement and prosperity in your career!

Apply Now!

Are you ready to take the next step in your career and thrive in a challenging work environment? If so, apply today and let's see where this opportunity can take you!

GEOTECHNICAL ENGINEER | TECHNICAL PROJECT MANAGER | PROFESSIONAL ENGINEER (PE) | AUTOCAD | CIVIL 3D | GEOTECHNICAL ANALYSIS | DAM & LEVEE DESIGN | STORMWATER MANAGEMENT | WETLAND RESTORATION | FOUNDATION DESIGN | HYDROLOGIC & HYDRAULIC ANALYSIS | CONSTRUCTION OVERSIGHT

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.

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

PrideNow is seeking an experienced Maintenance Electrician to join our team in a full-time, direct hire role. This position requires a highly skilled professional capable of performing complex industrial electrical maintenance in a manufacturing environment. Candidates with journeyman-level experience or 7–10 years of industrial electrical experience are strongly encouraged to apply.

Shifts Available:

• 2nd Shift: Monday–Friday, 2:00 PM–10:00 PM
• Pay Rate: $34.25/hr. plus $1 shift differential for 2nd shift
• Comprehensive benefits package to include Medical, Vision, Dental, PTO, 401k + Match, FSA etc.

Job Responsibilities:

• Identify electrical hazards and safely isolate, ground, and prepare circuits and equipment for repair.
• Use required PPE to protect against arc flash and electrical shock.
• Read, interpret, and troubleshoot from blueprints and schematics, including 240V and 480V three-phase systems.
• Troubleshoot and maintain motor control centers, motor start circuits, control loops, generators, high-voltage switchgear, protective relays, and related equipment.
• Install, calibrate, and maintain electrical apparatus using engineering drawings and manuals.
• Install conduit, pull wiring, and perform proper terminations.
• Use electrical and electronic testing equipment such as multimeters, ammeters, megohm meters, high-potential testers, oscilloscopes, and digital probes.
• Install and maintain electrical distribution and control equipment including switches, relays, circuit breakers, and panels.
• Install and maintain drive systems including VFDs, eddy current drives, and DC drive systems.
• Perform installation, maintenance, and troubleshooting of PLC systems, including point-to-point wiring and equipment replacement.
• Install and calibrate pressure, temperature, flow, and level control devices.
• Observe operating systems to detect hazards and determine need for adjustments or modifications.
• Design and lay out control panels, set up complex control systems, and modify engineering drawings when required.
• Repair or replace faulty electrical equipment, including electronic controls, motors, meters, outlets, and panels.
• Document work performed and communicate issues, irregularities, and ongoing needs to the team.
• Maintain a safe and clean work environment following all procedures and regulations.
• Communicate effectively to resolve electrical problems.
• Assist in training line mechanics and apprentices as needed.
• Use the computerized maintenance management system (CMMS) to enter and retrieve information.
• Follow safe work practices at all times and ensure work does not endanger others.
• Perform additional duties as needed.

Additional Requirement:

• Physical examination is required.
• Must be able to train on 1st shift for 1-2 weeks if needed
• Journeyman or electrical license preferred or 5+ years of experience as an electrician in a manufacturing plant

#SM

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

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.

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.