The Process Engineer is responsible for engineering & validation support activities during the tech transfer and day-to-day operations at the new start-up biologics facility. They are responsible for ensuring that all engineering activities associated with tech transfer, manufacturing activities and associated projects are completed.
- The Process Engineer will act as an SME on activities involving the design, specification, selection, equipment performance, engineering CQV, technical drawings, vendor management, engineering assessment of changes, validation activities, 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 team environment.
- As a key member of the start-up team on site play a key role in the commissioning and qualification and validations 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
- Ensure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.
- Lead Best practice Aseptic Technique principles current with the GXP/ GMP guidelines
- The Process Engineer will maximize the success rate for production operations by instituting programs to minimize failures. Support strategic plans for plant improvements in order to increase efficiency and drive down costs.
- Communicate plant operational status regularly to management at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
The next Process Engineer should have bachelor’s degree in a technical discipline with at least 5 years’ experience in Aseptic filling operations and/or upstream biotechnology processes in a GMP environment. Experience with filling equipment and control approaches (e.g. RABS and isolator) preferred.
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