Requirements: English
Company: BioTalent
Region: Stein , Argovia
Our client is seeking a highly skilled and motivated Commissioning & Qualification Engineer to join the Quality Control (QC) Laboratory project team. This role involves ensuring the successful commissioning, qualification, and ongoing validation of laboratory equipment, systems, and processes to comply with regulatory standards and ensure the highest levels of quality.
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 report 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, 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.
Candidate Profile:
- Bachelors 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.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance and Engineering
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