The Manufacturing Process Engineer will play a key technical role in a new state of the art ATMP (Advanced Therapy Medicinal Product) facility.
The Process Engineer is responsible for engineering support activities during the tech transfer and day-to-day operations. They are responsible for ensuring that all engineering activities associated with tech transfer, manufacturing activities and associated projects are completed as per approved Standard Operating Procedures (SOP’s).
- The Process Engineer will an SME on activities involving the design, specification, selection, equipment performance, engineering CQV, technical drawings, vendor management, engineering assessment of changes, conducting and leading investigations
- Pull together cross functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facility
- The Process Engineer will partake in specific manufacturing projects that arise on the process, equipment or systems providing a structured lean approach to problem resolution
- Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on removing barriers to maintain a highly effective and productive self-directed team environment.
- As a key member of the start-up team on site play a key role in the commissioning and qualification activities on site, acting as a lead end user for systems as they transition across to the operations teams. Ensure consistency between process design and technical SOPs
- The Process Engineer will lead Best practice Aseptic Technique principles current with the GXP/ GMP guidelines
- Provides significant contributions on project teams and may lead multi-functional teams on large multi-site project.
- Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
- Play a key role in developing process engineering related documents, technical SOPs, reviewing automation related functional design specifications and generating technical reports
The next Process Engineer should have a degree in Science or Engineering with 4+ years experience in the pharma/biopharma industry. You should have strong working knowledge of aseptci filling operations of upstream processes. Experience with filling equipment would be preferred.
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