Engineering Journal Jobs in Windsor New Jersey

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

Job Type: Full-time

Available Positions: 1

Location: On-Site

Application Deadline: March 30th, 2026

Opening Type: Existing Vacancy

Summary

The Packaging Engineer will support our production teams by developing precise drawings, layouts, and 3D models for custom products and packaging. This role plays a key part in turning concepts, measurements, and customer requests into designs, prototypes, and real solutions used on the production floor.

Key Activities

• Create and update 2D/3D CAD drawings, layouts, and technical specifications.
• Translate ideas, measurements, and customer requirements into accurate, sustainable designs.
• Assist with prototypes, project cost estimates, and test builds for new products.
• Work with production teams to ensure designs are feasible, efficient, and optimized for manufacturing.
• Maintain drawing files, revision histories, and documentation.
• Support R&D, cost-saving initiatives, and continuous improvement projects.
• Participate in design reviews and collaborate with sales, operations, and quality as needed.

Preferred Skills

• Strong aptitude for numbers and precise measurements.
• Prior packaging or manufacturing experience is preferred.

Educations & Experience

• 1-3 years of experience in packaging or structural design within a manufacturing, corrugated, consumer goods, or packaging industry.
• Experience designing corrugated packaging, folding cartons, displays, or protective packaging.

Are you looking for your next opportunity? We can help.

Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.

TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.

Accommodation for applicants with disabilities is available upon request.

Are you looking to hire? Get started here: hiring advice: all available opportunities: thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attached your resume to your application.

Job ID: 8198

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.

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

Company Description

JDC Energy Services, LLC (JDC), an affiliate of DCO Energy, LLC, and Joseph Jingoli and Son, Inc., is a leading energy engineering, procurement, and construction (EPC) firm. JDC specializes in self-funding energy efficiency projects for public and private clients through energy savings and comprehensive incentive programs. With expertise in demand-side energy management, supply-side optimization, and construction management, JDC provides cost-effective, energy-efficient upgrades to HVAC and lighting systems. Serving a diverse range of clients, JDC works with commercial, public, K-12, healthcare, higher education, manufacturing, gaming, industrial, and pharmaceutical entities to deliver measurable value and operational savings.

Role Description

This is a full-time hybrid role for an Energy Engineer II based between our Melville, New York and Lawrenceville, New Jersey offices with flexibility to work from home one day per week.

The Energy Engineer plays a key role in developing innovative energy conservation measures and demand‑side management strategies for buildings and facilities. Working closely with facility managers, this role conducts detailed energy assessments, performs on‑site investigations, and evaluates the performance of building systems.

The Energy Engineer prepares energy‑savings calculations, drafts clear and technically sound reports, and interprets engineering documents to support project planning and execution. They also monitor and support construction activities related to energy systems and equipment to ensure alignment with project specifications and industry standards.

In addition, the Energy Engineer provides technical expertise throughout project design and implementation to optimize system performance and achieve measurable energy and cost savings. The role also supports the Business Development team by evaluating potential opportunities and contributing technical insights during early‑stage project development

Responsibilities

• Performs technical energy audits and ECM payback calculations; drafts technical reports on findings.
• Provides engineering and technical support for project development and implementation and coordinates with facility personnel to optimize the operations and energy use of energy systems and equipment.
• Analyzes systems and equipment to determine optimum operating conditions and diagnose issues impacting energy consumption; develops and recommends strategies to maximize operating efficiency.
• Reviews data from Energy Management and Information Systems (EMIS), such as a building automation system, and utility billing and meter data to identify opportunities for energy and operational savings.
• Works with facility managers to implement effective and innovative energy conservation measures (ECMs) and demand-side management strategies in buildings and facilities.
• Researches, tests, and summarizes benefits of energy efficiency and renewable energy project concepts.
• Develops and delivers training on heating, ventilation, and air-conditioning (HVAC) controls and energy management for appropriate stakeholders.
• Advises on equipment specifications, conducts bidding process with equipment suppliers for upgrades and energy retrofits, and supports annual energy budget preparation.
• Reviews, monitors, and manages construction activities related to energy systems and equipment.
• Provides energy database support, including tracking and reporting of ECM and providing facility operational and use characteristics.
• Updates job knowledge by participating in educational opportunities, reading professional publications, maintaining professional networks, and participating in professional organizations.

Skills and Experience

• Knowledge of engineering practices and principles and experience in one or more of the following engineering fields: mechanical, environmental, civil, and electrical.
• Experience with building systems and equipment, including implementing energy efficiency measures and optimizing equipment use and scheduling to maximize energy and cost savings.
• Experience making routine determinations related to engineering principles and standards and offering recommendations for nonroutine matters.
• Experience interpreting engineering documents, evaluating construction plans, and using data from EMIS to monitor and control mechanical systems.
• Ability to perform technical analysis.
• Ability to verbally communicate technical and nontechnical information to various stakeholders.
• Familiarity with ASHRAE standards.
• Ability to manage time independently and meet schedules and deadlines.
• Ability to identify high-impact energy conservation measures and manager energy efficiency projects.

• Bachelor's degree in an applicable energy or engineering field, or other relevant degree from an accredited institution.

Engineer II – Mid Level (2–5 years)

• Demonstrated experience independently executing major portions of energy projects, including leading site assessments, performing energy and cost‑savings calculations, and managing technical deliverables. Capable of coordinating with facility staff, overseeing implementation tasks, and contributing to project planning and design.

Engineer III – Senior Level (5+ years)

• Extensive experience leading full‑cycle energy projects, from opportunity development through implementation and verification. Proven ability to manage client relationships, oversee multidisciplinary teams, develop advanced energy strategies, and ensure successful delivery of complex ECMs and system upgrades.

Take Your Environmental Career to the Next Level

Kleinfelder, a Forbes' Top Employer for Engineers in North America, is committed to a people-first culture, technical excellence, and creating opportunities where employees can thrive!

Are you ready to be challenged, make a difference, and experience professional growth in your career? Kleinfelder's Environmental team is looking for you! From environmental planning, permitting, remediation, and site characterization to chemical data management and hydrogeology, Kleinfelder offers a variety of services designed to provide technically appropriate and cost-effective solutions.

Step into Your New Role

As a Senior Civil / Environmental Engineer, you will work with our civil/environmental team performing technical evaluations, planning, design, and construction administration. This role will help lead, inspire, and support our civil and environmental disciplines, and most importantly help grow our portfolio of work with clients across multiple geographies, but primarily based in New Jersey.

This position is remote and will require approximately 40% travel to project sites primarily in New Jersey and other sites across the country.

Responsibilities:

• Strong experience with the design and construction of civil and/or environmental remediation projects.
• Leading technical efforts for planning, studies, budgeting, project cost estimating, technical management, coordination of multi-disciplinary engineering efforts, quality assurance, subcontract management and contract administration.
• Supervising staff and subcontractors to successfully deliver technical projects and build/mentor staff in the group.
• Ability to effectively communicate design concepts to clients, participating in project scoping activities and proposal presentations, and coordinating with clients to ensure an ongoing positive relationship.
• Establishing strong, productive internal collaborative relationships with senior management.

Qualifications:

• B.S. in civil, environmental, or chemical engineering.
• 12 + years of experience providing technical management of civil / environmental projects.
• Professional Engineering license with ability to obtain New Jersey license within 6 months of start date, if necessary.
• In-depth knowledge of large/complex civil/environmental projects and experience coordinating the various engineering disciplines for successful project completion.
• A strong work ethic with excellent organizational, communication, computer and technical writing skills.
• Strong team building and communications skills.
• Solid written and verbal fluency in English.
• Willingness to travel out of state.
• AutoCAD and Civil 3D experience preferred.

Move Forward with Kleinfelder

Kleinfelder has been connecting great people to the best work since 1961. We are engineers, scientists, and construction professionals providing solutions that improve our clients' transportation, water, energy, and other private infrastructure. As a responsive, cross-disciplinary team of bright, curious, and innovative problem-solvers, we are dedicated to doing the right thing, every day, on every project from over 85 offices in the US, Canada, and Australia. Connecting great people to the best work is our purpose - together, we deliver.

Progress with an Employer that Values You

Kleinfelder is an inclusive organization free from discrimination. We are a stronger organization when we are a diverse workforce and believe that throughdiversity, equity, and inclusion comes creativity, innovation, and unity. We are proud to offer the following:

Benefits: Kleinfelder offers an excellent compensation and benefits package, including medical, dental, vision, life insurance, 401(k) plan, and paid holidays.

New Jersey: The expected salary range for the position is displayed in accordance with the New Jersey Wage Transparency Law. Final agreed upon compensation is based upon individual qualifications and experience. Salary range: $131,000-$182,000.

Career Development: We are committed to investing in the professional development of our staff, offering each employee every opportunity to grow, develop, and take control of their career paths. We support these efforts through reimbursements for continuing education as well as many of the expenses associated with trainings and certifications, and opportunities for career development through our internal Mentoring Program.

Equal Opportunity: Kleinfelder is an Equal Opportunity Employer - Minorities/Women/Disabled/Veterans. (Compliant with the new VEVRAA and Section 503 rules)

NOTICE TO THIRD PARTY AGENCIES

Please note that Kleinfelder does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Fee Agreement, Kleinfelder will not consider or agree to payment for any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Kleinfelder explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resume, including those submitted to hiring managers, are deemed to be the property of Kleinfelder.

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.