Job Title: CQV Engineer
Locations (Hiring for 3 Separate Roles):
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Boston, MA
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Philadelphia, PA
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New Jersey (various project sites)
Job Type: Full-Time
Industry: Pharmaceutical Manufacturing & Life Sciences Consulting
Overview:
We are hiring three full-time CQV Engineers to support Commissioning, Qualification, and Validation (CQV) work for pharmaceutical projects in Boston, Philadelphia, and New Jersey. Each role is location-specific, with no travel required between sites. These positions offer the opportunity to work on high-impact, regulated life sciences projects involving facilities, utilities, and process equipment.
Key Responsibilities:
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Execute CQV activities for site-specific facilities, utilities, and process equipment, including but not limited to:
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Clean utilities (WFI, PW, Clean Steam)
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Black utilities (HVAC, Chillers, Boilers, Compressors)
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Process equipment (bioreactors, CIP/SIP skids, isolators, lyophilizers, filtration systems, etc.)
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Prepare, review, and execute GMP documentation: URS, DQ, FAT, SAT, IQ, OQ, PQ protocols.
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Support facility startup, equipment commissioning, and validation readiness within GMP frameworks.
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Collaborate with on-site teams: Engineering, QA, Validation, Operations, and external vendors.
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Ensure all activities align with FDA, EMA, cGMP, and ICH Q8-Q10 regulatory requirements.
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Manage deviations, change controls, CAPAs, and risk assessments related to CQV deliverables.
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Report project progress to site leadership and ensure timely closeout of validation activities.
Requirements:
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Bachelor’s degree in Engineering (Mechanical, Chemical, Biotech, or related discipline).
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2-10+ years of experience in CQV roles within pharmaceutical or biotechnology manufacturing.
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Hands-on experience with qualification of facilities, utilities, and process systems.
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Strong understanding of GMP, validation lifecycle, and regulatory compliance.
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Proficiency in technical writing and GMP documentation.
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Candidates must be based near or willing to commute to one of the hiring locations (Boston, Philadelphia, or New Jersey).
What’s Offered:
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Competitive full-time salary and benefits
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Long-term, local project work with no travel required
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Opportunity to contribute to meaningful, patient-impacting pharma projects
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Structured career development and ongoing technical training
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Supportive project teams and collaborative environments
Note: These are full-time, on-site positions. Applicants must be authorized to work in the U.S. without sponsorship.
Darwin Recruitment is acting as an Employment Business in relation to this vacancy.
Asha Longman