Shoolin Inc · 19 hours ago
CQV Engineer
Massachusetts, United States
Contract
Onsite
Senior Level
5+ years expShoolin Inc is seeking a mid-level CQV Engineer to support commissioning, qualification, and validation activities at a GMP-regulated bio-pharmaceutical manufacturing facility. This role focuses on hands-on execution, project delivery, equipment startup, and ensuring compliance with regulatory and site requirements.
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Hiring Manager
Aadil Shaikh
Responsibilities
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&ID walkdowns and component verifications
Support cleaning validation, temperature mapping, and requalification activities
Collaborate with Engineering, QA, Automation, and Construction teams to ensure GMP compliance
Qualification
Required
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 (DeltaV, Rockwell, SCADA or similar)
Experience performing P&ID walkdowns, loop checks, functional testing, FAT/SAT support
Controlled Temperature Environment (CTE) temperature mapping experience
Proficiency with validation tools such as ValGenesis, Kneat, or Veeva VMS
Company
Shoolin Inc
Shoolin-Inc staffing, specializes in providing world class recruiting services to companies in the Healthcare, IT, and Engineering sectors.
51-200 employees
H1B Sponsorship
Shoolin Inc has a track record of offering H1B sponsorships. Please note that this does not
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2025 (81)
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2023 (48)
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2021 (29)
2020 (18)
Funding
Current Stage
Growth StageCompany data provided by crunchbase