Katalyst CRO · 15 hours ago
CQV Engineer
South Plainfield, NJ
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking an experienced CQV Engineer who enjoys owning equipment projects from concept to production in a highly regulated pharmaceutical environment. The role involves evaluating vendors, leading commissioning and qualification, and developing SOPs to ensure equipment readiness for GMP production.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Evaluate vendors, review quotes, and recommend equipment
Lead commissioning, qualification, and validation (IQ/OQ)
Develop SOPs, manage change control, and deliver equipment ready for GMP production
You'll be working directly with manufacturing and packaging equipment, reviewing machine manuals and electrical drawings, and driving small projects end-to-end not as a traditional project manager, but as a technical CQV owner
Qualification
Required
5+ years of CQV experience
Hands-on equipment validation background
Experience in pharma / biotech / regulated manufacturing
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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