Lead CQV (Commissioning, Qualification & Validation)

Join our team as a Commissioning and Qualification Engineer and play a crucial role in the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities. In this role, you will generate test packages, coordinate and execute commissioning and qualification processes, and provide operational expertise.

Responsibilities:

• Generate commissioning and qualification test packages or support others in generating respective documents. Coordination and execution of commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ)
• Carry out the commissioning and qualification within a plant environment. Including interacting with plant equipment and Upstream and Downstream Processes (USP/DSP)
• Create test plans for qualification, support and cooperation with QA
• Regularly reports the status of assigned work
• Brings operational experience during the commissioning and qualification phase
• Support automation engineers with operational know-how

• Minimum 2 to 8 years of experience in commissioning and qualification of equipment in new pharmaceutical/biotech manufacturing facilities
• Hands-on process engineering and/or operational experience
• Good GMP skills for completing qualification documentation
• Prior knowledge of working on plants operated with an MES is preferable.
• Experience in plant planning, and project management with a focus on plant automation or projects in technical computer science
• Fluent in English