Validation Engineer Jobs in New Jersey
Validation Engineer jobs in New Jersey are open across Branchburg, Bridgewater, and Hoboken and other New Jersey metros, with employers like Katalyst Healthcares & Life Sciences, AbbVie, and Celgene Corporation hiring at every experience level. Find a role that fits below and apply directly.
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Showing 5 of 8+ Validation Engineer jobs
Job Description:
The Lead Validation Engineer leads GMP equipment installation, commissioning, and qualification projects supporting large-molecule biologics manufacturing. This role supports upstream and downstream processes and ensures projects are executed safely, on schedule, and in compliance with regulatory and quality requirements.
Responsibilities:
- Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufacturing systems including bioreactors, media/buffer preparation, chromatography, filtration, and associated utilities.
- Drive project planning and execution, developing and maintaining integrated schedules, budgets, and resource plans while proactively identifying risks and implementing mitigation strategies to support on-time, compliant delivery.
- Coordinate and direct cross-functional teams (Engineering, Manufacturing, MSAT, Quality, Validation, Automation, and vendors) to ensure alignment on technical requirements, execution strategy, and readiness for qualification milestones.
- Ensure full regulatory and quality compliance, including adherence to cGMP, biosafety requirements, and site quality systems; review and approve URSs, FAT/SAT documentation, installation packages, and qualification protocols.
- Serve as the primary technical and communication lead for equipment CQV activities, providing regular status updates to stakeholders and supporting change controls, deviations, and CAPAs related to equipment implementation and qualification.
- Lead CQV activities for facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI (reverse osmosis deionized) water skid upgrades, parts washer upgrades, and installation and qualification of autoclaves.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical field; advanced degree or relevant certifications (e.g., CQV, PMP) preferred
- 7+ years of progressive experience in Commissioning, Qualification, and Validation (CQV) within GMP-regulated pharmaceutical or biotechnology manufacturing environments
- Demonstrated experience leading GMP equipment and utility projects from installation through IQ, OQ, and PQ, supporting biologics manufacturing processes such as CHO cell culture, media/buffer preparation, chromatography, filtration, and clean utilities
- Strong working knowledge of cGMP regulations, biosafety requirements, and site quality systems, with experience supporting regulatory inspections and audit readiness
- Proven ability to lead cross-functional teams and vendor partners, manage project schedules and budgets, and communicate technical status, risks, and mitigation plans to stakeholders
- Hands-on experience reviewing and approving URSs, FAT/SAT documentation, installation packages, qualification protocols, and supporting change controls, deviations, and CAPAs
- Preferred experience supporting facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI water skid upgrades, parts washer upgrades, and installation/qualification of autoclaves
Job Description:
The Lead Validation Engineer leads GMP equipment installation, commissioning, and qualification projects supporting large-molecule biologics manufacturing. This role supports upstream and downstream processes and ensures projects are executed safely, on schedule, and in compliance with regulatory and quality requirements.
Responsibilities:
- Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufacturing systems including bioreactors, media/buffer preparation, chromatography, filtration, and associated utilities.
- Drive project planning and execution, developing and maintaining integrated schedules, budgets, and resource plans while proactively identifying risks and implementing mitigation strategies to support on-time, compliant delivery.
- Coordinate and direct cross-functional teams (Engineering, Manufacturing, MSAT, Quality, Validation, Automation, and vendors) to ensure alignment on technical requirements, execution strategy, and readiness for qualification milestones.
- Ensure full regulatory and quality compliance, including adherence to cGMP, biosafety requirements, and site quality systems; review and approve URSs, FAT/SAT documentation, installation packages, and qualification protocols.
- Serve as the primary technical and communication lead for equipment CQV activities, providing regular status updates to stakeholders and supporting change controls, deviations, and CAPAs related to equipment implementation and qualification.
- Lead CQV activities for facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI (reverse osmosis deionized) water skid upgrades, parts washer upgrades, and installation and qualification of autoclaves.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical field; advanced degree or relevant certifications (e.g., CQV, PMP) preferred
- 7+ years of progressive experience in Commissioning, Qualification, and Validation (CQV) within GMP-regulated pharmaceutical or biotechnology manufacturing environments
- Demonstrated experience leading GMP equipment and utility projects from installation through IQ, OQ, and PQ, supporting biologics manufacturing processes such as CHO cell culture, media/buffer preparation, chromatography, filtration, and clean utilities
- Strong working knowledge of cGMP regulations, biosafety requirements, and site quality systems, with experience supporting regulatory inspections and audit readiness
- Proven ability to lead cross-functional teams and vendor partners, manage project schedules and budgets, and communicate technical status, risks, and mitigation plans to stakeholders
- Hands-on experience reviewing and approving URSs, FAT/SAT documentation, installation packages, qualification protocols, and supporting change controls, deviations, and CAPAs
- Preferred experience supporting facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI water skid upgrades, parts washer upgrades, and installation/qualification of autoclaves
See All 8 Validation Engineer Jobs in New Jersey
Find roles in New Jersey that match your experience and apply in just a few clicks.
Find Validation Engineer JobsValidation Engineer Jobs by City in New Jersey
Where New Jersey roles are concentrated, by current openings.
Validation Engineer Job Market in New Jersey
A snapshot from current New Jersey openings, updated as new roles post.
Who's Hiring
- Katalyst Healthcares & Life Sciences2
- AbbVie1
- Celgene Corporation1
- Cellares1
- Nokia1
Top Industries Hiring
- Consulting & Professional Services3
- Biotechnology & Pharmaceuticals2
- Chemicals & Materials1
- Construction & Real Estate1
What New Jersey Employers Look For
The qualifications that appear most often in validation engineer jobs across New Jersey.
- Bachelor's degree in engineering, life sciences, or a related technical field
- Experience authoring and executing IQ, OQ, and PQ validation protocols
- Working knowledge of FDA 21 CFR Part 11, Part 820, or ISO 13485 regulations
- Proficiency with CAPA systems and deviation management documentation
- Familiarity with GAMP 5 guidelines for computerized system validation
- Experience using electronic quality management systems such as Veeva or MasterControl
Validation Engineer Jobs in New Jersey: Frequently Asked Questions
How many validation engineer jobs are there in New Jersey?
There are 8+ validation engineer openings in New Jersey on Migrate Mate as of June 2026, with the most roles in Branchburg, Bridgewater, and Hoboken. New positions post regularly as employers across New Jersey hire.
Which New Jersey cities have the most validation engineer jobs?
Branchburg, Bridgewater, and Hoboken have the most validation engineer openings in New Jersey right now, with additional roles spread across smaller metros statewide.
Which companies hire validation engineers in New Jersey?
Employers hiring validation engineers in New Jersey include Katalyst Healthcares & Life Sciences, AbbVie, and Celgene Corporation, based on current listings on Migrate Mate as of June 2026.
Are there remote validation engineer jobs in New Jersey?
Yes. About 0% of validation engineer openings tied to New Jersey are remote or hybrid as of June 2026. The rest are on-site roles based in New Jersey metros.
How do I apply for validation engineer jobs in New Jersey?
You can apply to validation engineer jobs in New Jersey directly on Migrate Mate. Search the listings above, find roles that match your experience and preferred New Jersey location, then apply to each one that fits.
See All 8 Validation Engineer Jobs in New Jersey
Find roles in New Jersey that match your experience and apply in just a few clicks.
Find Validation Engineer Jobs