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Commissioning and Qualification Engineer, Stein
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Job Reference:
JN -122024-101962_1734511683
Job Views:
20
Posted:
18.12.2024
Expiry Date:
01.02.2025
Job Description:
We are seeking a skilled C&Q Specialist to lead commissioning and qualification activities for QC laboratory systems, equipment, and support utilities. This role ensures compliance with GMP standards and regulatory requirements while supporting cross-functional teams and external vendors.
Key Responsibilities:
1. Act as SME for QC laboratory C&Q scope.
2. Plan, coordinate, and execute commissioning and qualification for lab systems (e.g., analytical instruments, HVAC, water systems).
3. Develop and review protocols (IQ/OQ/PQ), validation plans, and reports.
4. Coordinate with CSV and global IT teams.
5. Identify and resolve risks, troubleshoot issues, and implement corrective actions.
6. Maintain and report C&Q status to stakeholders.
Candidate Profile:
1. Bachelor’s degree in Life Sciences or Engineering.
2. 5+ years of CQV experience in a GMP environment.
3. Proficiency with laboratory instruments (e.g., HPLC, GC, UV-Vis) and CSV for lab systems.
4. Strong knowledge of IQ/OQ/PQ processes and regulatory standards (FDA, EMA, ISO).
5. Experience with Kneat for CQV execution is an advantage.
6. Excellent communication skills and cGMP knowledge.
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