Qualification Execution Engineer
About the Role
Key Responsibilities
- Participate in SAT execution and review SAT reports.
- Lead full qualification execution (IQ, OQ, PQ) for systems such as:
- Manufacturing equipment (Filter-Dryer, vessel skids, pumps, etc.)
- Cold/freezer rooms
- Unidirectional flow hoods
- Purified Water and Nitrogen Systems
- Cleanroom classification
- Prepare execution plans, including materials and team coordination.
- Gather documentation (FAT, SAT, supplier docs) for IQ/OQ.
- Identify and troubleshoot technical issues during qualification, proposing effective solutions.
- Conduct IQ, OQ, and PQ with cross-functional teams (Production, Maintenance, QC).
- Collect test results, identify non-conformances, and escalate as needed.
- Provide technical support to the qualification team.
Profile We're Looking For
- Experience: Some experience in Pharma (at least understanding qualification and GMP environment).
- Availability: January to end of April 2026.
- Commitment: Must be onsite 100%.
- Strong technical background and problem-solving skills.
Reporting Line
Reports to Qualification Lead / Qualification Engineer.
Interfaces
- External: Equipment suppliers, service providers (calibration, materials, labs).
- Internal: Qualification Group, QA, Production, Engineering, QC, Industrialization.
FAQs
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