CQV Engineer- US

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