The Life Science Career Network – CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services,

For our client, a leading CDMO company located in the Basel area, we are looking for a

C&Q Engineer QC Lab (6269)

in a 12 months contract initially.

The C&Q Engineer will play a crucial role in supporting the setup, qualification, validation, and maintenance of laboratory environments.

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 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 reporting of C&Q status to the C&Q Lead, which can be reported into project stakeholders meetings (e.g. Tier 1 meetings, Wall meetings).

• Generate, review, 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.

 Profile:

• 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 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.

Interested? Contact us!

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