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Commissioning and Qualification Specialist
2 weeks ago
At AM Group, we strive to challenge the norm in consulting. Our approach involves utilizing established management and engineering tools to deliver tangible improvements to our clients' businesses.
We bring the experience to know when to do what and apply it with your people so they can learn and take over when our job is done. We apply simple, reliable management tools to improve our clients' business.
Job Summary:
A Commissioning and Qualification Engineer plays a crucial role in the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities. This role generates test packages, coordinates and executes commissioning and qualification processes, and provides operational expertise.
Responsibilities:
- Generate commissioning and qualification test packages or support others in generating respective documents. Coordinate and execute commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ).
- Carry out 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 report the status of assigned work.
- Bring operational experience during the commissioning and qualification phase.
- Support automation engineers with operational know-how.
Requirements:
- 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.
- 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.
