We are seeking a highly skilled and motivated Commissioning & Qualification Engineer to join the Quality Control (QC) Laboratory project team in Stein. 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.
Key Responsibilities:
1. C&Q SME for QC Laboratory scope.
2. 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).
3. Coordinate execution activities with supporting CSV Team and global IT teams.
4. Lead C&Q testing activities supported by external vendors and/or contractors.
5. Develop any supporting validation plans related to scope of execution.
6. Develop and review Qualification Protocols (IQ/OQ/PQ), commissioning documents, and final reports, ensuring compliance with relevant standards (GxP, FDA, EMA, ISO, etc.).
7. Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
8. 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).
9. Generate, review, approve CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures.
10. Identify potential risks or issues during commissioning and qualification activities and lead troubleshooting efforts when necessary. Implement corrective actions as needed.
11. Assist the C&Q Lead with the Handover and Release process.
Qualification:
1. Bachelor’s degree in Life Sciences or Engineering, or a related field.
2. 5+ years of commissioning, qualification, or validation experience in a GMP environment in a Life Sciences relevant discipline.
3. Familiarity with laboratory instruments such as HPLC, GC, UV-Vis spectrophotometers, and other analytical equipment.
4. Experience with computer systems validation (CSV) for laboratory systems.
5. Previous experience in authoring CQV lifecycle documents necessary.
6. Strong knowledge of qualification and validation processes for laboratory systems and equipment.
7. Excellent problem-solving skills and attention to detail.
8. Strong communication and collaboration skills.
9. Experience in the preparation and review of IQ/OQ/PQ protocols and reports.
10. Experience using Kneat for CQV test execution.
11. Fluent English language written and verbal communication skills.
Additional Information:
1. This is an exciting opportunity for a strategic thinker who thrives in a collaborative, fast-paced environment.
2. We are offering a competitive salary and benefits package.
3. Workload: 100%
4. Location: Stein, Switzerland.
5. Start Date: January 1, 2025, 12 months contract, with an option for extension.
6. The role is 100% on-site in Stein with no possibility for home office as all the tasks are in the QC Lab.
#J-18808-Ljbffr