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.
Key Responsibilities
- 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.
Qualifications & Experience
- 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
