CQV Engineer
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-02-12
Listing for:
Shoolin Inc
Full Time
position Listed on 2026-02-12
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
We are seeking a mid-level CQV Engineer to support commissioning, qualification, and validation activities at a GMP-regulated bio-pharmaceutical manufacturing facility. This is a hands-on, execution-focused role supporting project delivery, equipment startup, and compliance with regulatory and site requirements.
Required Experience:- 5+ years of CQV / C&Q / Validation experience in pharmaceutical, biotech, or medical device industry
- Hands-on execution of IQ, OQ, PQ including protocol writing and report generation
- Experience with GMP utilities (WFI, clean steam, compressed air, HVAC, process gases, CIP/SIP)
- Experience qualifying process equipment (bioreactors, chromatography skids, TFF, centrifuges, autoclaves, washers, tanks, lyophilizers, HPLC, etc.)
- Independent Cleaning Validation protocol generation and execution (minimum 1+ year)
- Experience with commissioning and decommissioning activities
- Exposure to automation-controlled systems (Delta
V, Rockwell, SCADA or similar) - Experience performing P&, loop checks, functional testing, FAT/SAT support
- Controlled Temperature Environment (CTE) temperature mapping experience
- Proficiency with validation tools such as Val Genesis, Kneat, or Veeva VMS
- Execute commissioning, qualification, and validation activities for utilities, process equipment, and automation systems
- Author and execute URS, FS, IQ, OQ, PQ, TM, and commissioning documentation
- Perform equipment installation verification, functional testing, and issue resolution
- Support FAT/SAT, punch list management, turnover packages, and traceability matrices
- Conduct P& and component verifications
- Support cleaning validation, temperature mapping, and requalification activities
- Collaborate with Engineering, QA, Automation, and Construction teams to ensure GMP compliance
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×