Senior Validation Engineer Consultant

We are seeking a Commissioning and Qualification Engineer to support the installation, startup, commissioning and qualification of new single-use bioprocess equipment. The engineer will work closely with Process Engineering, Automation, CSV, Quality, equipment vendors and Operations. This position requires strong equipment and process knowledge, with the ability to translate process requirements into meaningful commissioning and qualification testing. Senior Validation Engineer Responsibilities:

Validation Engineer Position Summary: Work Schedule: Monday - Friday, 8:00am to 5:00pm100% on-site The Chelsea facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest Good Manufacturi

Job Summary: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer S

Job Description: Lead second shift CQV execution activities across multiple systems and workstreams Coordinate daily execution priorities to recover schedule slippage and maintain timelines Interface with QA, Engineering, and Operations to resolve issues in real time Oversee execution of IQ/OQ protocols and operational verification activities Responsibilities: Drawing walkdowns Equipment and component verification Materials of Construction (MOC) and weld verification Provide oversight for temper