Commissioning and Qualification Engineer

Vor 2 Tagen


Stein AR, Schweiz Darwin Recruitment GmbH Vollzeit

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Commissioning and Qualification Engineer, SteinLocation:Job Category: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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