Commissioning Engineer - Cleaning Validation
Location: Dublin, Ireland ( Onsite)
Contract Duration: 12 Months
About the Role:
We are looking for a Commissioning Engineer Cleaning Validation to take the lead on validating critical cleaning processes. You'll design, execute, and optimize cleaning validation protocols, analyze data, and ensure all processes meet GMP and FDA standards. This role gives you the chance to solve technical challenges, improve processes, and directly impact product quality and patient safety.
Key Responsibilities:
- Execute all cleaning validation sampling activities (swab and rinse) for new products and process changes
- Prepare samples, manage LIMS entries, and coordinate submission to QC for analysis
- Correlate QC results with cleaning protocols and logbooks
- Support product changeovers and LOTO activities as required
- Generate cleaning validation documentation, including ECPs, protocols, reports, and release memos
- Provide QMS investigation support and troubleshoot cleaning validation issues
- Oversee visual inspection qualification and requalification activities
- Act as CQV representative within project teams, collaborating cross-functionally
- Ensure adherence to GMP, site procedures, and global regulatory standards
- Deliver cleaning validation activities in line with project schedules and deadlines
What You'll Bring:
- Bachelor's in Engineering, Chemistry, or related field.
- Proven experience in pharmaceutical cleaning validation.
- Strong knowledge of GMP, FDA, and regulatory compliance.
- Excellent analytical, problem-solving, and communication skills.
