Commissioning Qualification Validation Engineer
Duration: 12 months
Working hours: 39 hours
Onsite requirements: 50/50 hybrid – onsite full time during execution phase (expected to be summer 2026)
Engagement Type: LTD Company Contractor
Legal Right to Work: Candidates must have the legal right to work in Ireland. This role does not offer sponsorship.
This role is for a client of ours. The client operates in the biopharmaceutical drug substance manufacturing industry.
Job Overview
The Cleaning Validation Engineer will support cleaning validation activities for a new product introduction (NPI) tech transfer into a multi-product GMP drug substance manufacturing facility. The role will primarily focus on cleaning sampling execution, QC result correlation, and generation/approval of cleaning validation documentation within a small, specialist CQV team.
Responsibilities
Execute cleaning validation sampling, including swab and rinse collection.
Perform sample preparation and coordinate submission to QC for analysis.
Administer LIMS workflows and support sample traceability.
Correlate QC results with cleaning changeover protocols and logbooks.
Support product changeover and equipment release activities.
Generate and standardise Energy Control Plans (ECPs) and cleaning validation documents.
Assist with LOTO (Lockout/Tagout) where required.
Provide investigation and troubleshooting support within QMS.
Prepare and issue cleaning validation release memos.
Liaise with cross‑functional teams to ensure timely approval of deliverables.
Maintain compliance with site and global GMP procedures and regulatory guidelines.
Deliver workstream tasks to project deadlines within a team of 4 FTEs.
Requirements
Minimum of a Bachelor’s degree in a scientific, technical, or engineering discipline.
2+ years of experience in a GMP environment.
Hands‑on cleaning validation execution experience, with strong preference for biopharmaceutical or multi‑product facilities.
Direct experience performing swab and rinse sampling.
Experience in sample preparation and submission to QC.
LIMS exposure or administration experience.
Strong understanding of cGMP and contamination control.
Ability to work onsite full time during the Summer 2026 execution period.
Nice to Have
Biopharmaceutical process validation knowledge.
Experience in drug product filling or sterile manufacturing environments.
Seniority level: Mid-Senior level
Employment type: Contract
Job function and industry: Engineering and Manufacturing; Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing
Location: Dublin, County Dublin, Ireland
#J-18808-Ljbffr