Darwin Recruitment
Job Title:
CQV Engineer
Locations (Hiring for 3 Separate Roles): Boston, MA
Philadelphia, PA
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:
Execute CQV activities for site-specific
facilities ,
utilities , and
process equipment , including but not limited to: Clean utilities (WFI, PW, Clean Steam)
Black utilities (HVAC, Chillers, Boilers, Compressors)
Process equipment (bioreactors, CIP/SIP skids, isolators, lyophilizers, filtration systems, etc.)
Prepare, review, and execute GMP documentation: URS, DQ, FAT, SAT, IQ, OQ, PQ protocols.
Support facility startup, equipment commissioning, and validation readiness within GMP frameworks.
Collaborate with on-site teams: Engineering, QA, Validation, Operations, and external vendors.
Ensure all activities align with FDA, EMA, cGMP, and ICH Q8-Q10 regulatory requirements.
Manage deviations, change controls, CAPAs, and risk assessments related to CQV deliverables.
Report project progress to site leadership and ensure timely closeout of validation activities.
Requirements:
Bachelor’s degree in Engineering (Mechanical, Chemical, Biotech, or related discipline).
2-10+ years of experience in CQV roles within pharmaceutical or biotechnology manufacturing.
Hands-on experience with qualification of
facilities ,
utilities , and
process systems .
Strong understanding of GMP, validation lifecycle, and regulatory compliance.
Proficiency in technical writing and GMP documentation.
Candidates must be based near or willing to commute to one of the hiring locations (Boston, Philadelphia, or New Jersey).
What’s Offered:
Competitive full-time salary and benefits
Long-term, local project work with no travel required
Opportunity to contribute to meaningful, patient-impacting pharma projects
Structured career development and ongoing technical training
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
#J-18808-Ljbffr
CQV Engineer
Locations (Hiring for 3 Separate Roles): Boston, MA
Philadelphia, PA
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:
Execute CQV activities for site-specific
facilities ,
utilities , and
process equipment , including but not limited to: Clean utilities (WFI, PW, Clean Steam)
Black utilities (HVAC, Chillers, Boilers, Compressors)
Process equipment (bioreactors, CIP/SIP skids, isolators, lyophilizers, filtration systems, etc.)
Prepare, review, and execute GMP documentation: URS, DQ, FAT, SAT, IQ, OQ, PQ protocols.
Support facility startup, equipment commissioning, and validation readiness within GMP frameworks.
Collaborate with on-site teams: Engineering, QA, Validation, Operations, and external vendors.
Ensure all activities align with FDA, EMA, cGMP, and ICH Q8-Q10 regulatory requirements.
Manage deviations, change controls, CAPAs, and risk assessments related to CQV deliverables.
Report project progress to site leadership and ensure timely closeout of validation activities.
Requirements:
Bachelor’s degree in Engineering (Mechanical, Chemical, Biotech, or related discipline).
2-10+ years of experience in CQV roles within pharmaceutical or biotechnology manufacturing.
Hands-on experience with qualification of
facilities ,
utilities , and
process systems .
Strong understanding of GMP, validation lifecycle, and regulatory compliance.
Proficiency in technical writing and GMP documentation.
Candidates must be based near or willing to commute to one of the hiring locations (Boston, Philadelphia, or New Jersey).
What’s Offered:
Competitive full-time salary and benefits
Long-term, local project work with no travel required
Opportunity to contribute to meaningful, patient-impacting pharma projects
Structured career development and ongoing technical training
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
#J-18808-Ljbffr