This opportunity requires long-term relocation to the Copenhagen area in Denmark.
Consultys provides work visa sponsorship for this position.
Job Summary
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
Requirements:
- Minimum 5 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
