Validation & Commissioning Engineer
Listed on 2026-03-10
-
Engineering
Validation Engineer, Manufacturing Engineer -
Manufacturing / Production
Validation Engineer, Manufacturing Engineer
Duration: 6+ Months Contract
Job Description:The Senior CQV Engineer will support commissioning, qualification, and validation (CQV) activities for new manufacturing equipment and systems. Responsibilities include equipment receipt verification, ETOP documentation, and authoring/executing IQ/OQ/PQ protocols. The role involves collaborating with engineering and automation teams, preparing validation reports and traceability documents, and ensuring compliance with GMP regulations such as 21 CFR Part 11 and data integrity standards. Experience in biologics manufacturing, aseptic processing, fill/finish, or lyophilization is preferred.
Required Qualifications:10+ years of experience in Commissioning, Qualification, and Validation (CQV) within capital projects.
Strong technical knowledge of biologics manufacturing processes and related equipment.
Experience with aseptic processing, fill-finish operations for ADC vials, and lyophilization is preferred.
Solid understanding of regulatory requirements including 21 CFR Part 11 and Data Integrity (ALCOA+).
Proven ability to work independently and manage projects in a fast-paced GMP manufacturing environment.
High-potency manufacturing experience is preferred.
#J-18808-Ljbffr(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).