Validation and Commissioning Specialist
1 week ago
At AM Group, we challenge the norm in consulting by utilizing well-established management and engineering tools to deliver tangible improvements to our clients' businesses.
We bring experience to know when to act and do it with your people so they can learn and take over when our job is done. Our approach applies simple, reliable management tools to improve our clients' business.
Job Summary:
We are seeking a skilled Commissioning and Qualification Engineer to play a crucial role in the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities.
The ideal candidate will generate test packages, coordinate and execute commissioning and qualification processes, and provide operational expertise.
Key Responsibilities:
- Develop commissioning and qualification test packages or support others in generating respective documents. Coordinate and execute commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ).
- Perform commissioning and qualification within a plant environment, including interacting with plant equipment and Upstream and Downstream Processes (USP/DSP).
- Create test plans for qualification, supporting QA teams.
- Regularly report the status of assigned work.
- Bring operational experience during the commissioning and qualification phase.
- Support automation engineers with operational knowledge.
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 desirable.
- Experience in plant planning and project management with a focus on plant automation or projects in technical computer science.
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