Commissioning & Qualification (CQV) Engineer - Cleaning Validation / Samples Focus
Duration:
12 months
Location:
Cruiserath, Dublin, Ireland
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
Day Rate:
€420 per day (420 euros per day)
Legal Right to Work:
Candidates must have the legal right to work in Ireland. This role does not offer sponsorship.
Atrium Global Summary
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.
* Support visual inspection qualification/requalification activities.
* 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
(optional - included based on preferences shared)
* Biopharmaceutical process validation knowledge.
* Experience in drug product filling or sterile manufacturing environments.
* Equipment visual inspection qualification experience.