Cleaning Validation Engineer

Our client, a leading Biopharmaceutical in Dublin is looking for a Cleaning Validation Engineer who will be responsible for cleaning validation activities relating to tech transfer of a new product introduction (NPI) to the manufacturing facility.

This position will work across CQV workstreams with an initial focus on cleaning validation for NPI.

• Performing all aspects of cleaning sampling required for cleaning validation for a new product.
• Activities include swab and rinse sampling, sample preparation, LIMS administration, submission to QC for analysis, correlation of QC results with cleaning change over protocols/ cleaning logbooks.
• Supporting product changeover activities.
• Assisting with LOTO (lockout/ Tagout) activities where required.
• Generation of standardized cleaning validation ECPs (Energy Control Plans).
• Generation of cleaning validation documentation for new product introductions, process changes, audit observations and other required actions.
• Investigation support using QMS (Quality Management Systems) and troubleshooting for cleaning validation issues.
• Cleaning validation release memos to support product release.
• Oversight of the visual inspection qualification and requalification process on site.
• Adhering to project deadlines as scheduled by the project manager.
• Inputting to a wider projects team as CQV representative and liaising with cross-functional teams to ensure timely completion and approval of cleaning validation deliverables.
• Investigation support using QMS (Quality Management Systems) and troubleshooting for cleaning validation issues.
• Ensuring adherence to governing site and global procedures and regulatory guidelines.

• The candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline.
• Previous cleaning validation experience is an advantage.
• The ideal candidate would have biopharmaceutical Process / Validation knowledge.
• Exposure to cGMP in a fast-paced environment is required.
• Previous experience in working in a drug product filling facility would be advantageous.
• Onsite presence required