C&Q Engineer – QC Lab

Vor 7 Tagen

Stein, Schweiz NRL Vollzeit

Responsibilities:

  • C&Q SME for QC Laboratory scope.

  • Plan, coordinate, and execute commissioning and qualification activities for QC laboratory systems, equipment, and support utilities as needed (e.g., analytical instruments, laboratory systems, HVAC, and water systems).

  • Coordination of execution activities with supporting CSV Team and global IT teams.

  • Lead C&Q testing activities supported by external vendors and/or contractors.

  • Develop any supporting validation plans related to the scope of execution.

  • Develop and review Qualification Protocols (IQ/OQ/PQ), commissioning documents, and final reports, ensuring compliance with relevant standards (GxP, FDA, EMA, ISO, etc.).

  • Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.

  • Maintain and report C&Q status to the C&Q Lead, which can be reported into project stakeholder meetings (e.g., Tier 1 meetings, Wall meetings).

  • Generate, review, and approve CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures.

  • Identify potential risks or issues during commissioning and qualification activities and lead troubleshooting efforts when necessary. Implement corrective actions as needed.

  • Assist the C&Q Lead with the Handover and Release process.


Requirements:

  • Bachelor’s degree in Life Sciences or Engineering.

  • 5+ years of commissioning, qualification, or validation experience in a GMP environment in a Life Sciences relevant discipline.

  • Familiarity with laboratory instruments such as HPLC, GC, UV-Vis spectrophotometers, and other analytical equipment.

  • Experience with computer systems validation (CSV) for laboratory systems.

  • Previous experience in authoring CQV lifecycle documents is necessary.

  • Strong knowledge of qualification and validation processes for laboratory systems and equipment.

  • Experience in the preparation and review of IQ/OQ/PQ protocols and reports.

  • Experience using Kneat for CQV test execution.

  • Fluent English language written and verbal communication skills.

  • cGMP knowledge and knowledge of regulatory requirements.

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