Just-Evotec Biologics is seeking a motivated and creative Process Engineer to lead the design and development of new equipment, technologies, and single-use materials for the manufacturing network. The role will lead cross-functional evaluations of technologies to improve and optimize the biomanufacturing platform and provide technical and operational support to Just-Evotec’s Site MSAT and Manufacturing Operations groups.
Requirements
- Develop strategies for the design and development of new and existing technologies across the Just-Evotec Biological Manufacturing network.
- Develop the lifecycle and maintenance management program for GMP equipment and technologies.
- Support the evaluation and approval of innovative technologies within the manufacturing platform through the project governance group.
- Work with key stakeholders and vendors to evaluate innovative technologies for implantation into the manufacturing process to increase efficiency and facility throughput.
- Collaborate with the automation team on design and development of the Distribute Control System (DCS) with the manufacturing suite and integration of PLC based systems into the DCS.
- Support technical evaluations of the facility utility requirements, layouts within the manufacturing area and support associated CQV (Commissioning, Qualification, and Validation) activities.
- Evaluate single-use technologies for data acquisition and suitability within single-use manifolds and assemblies.
- Work with vendors to test and develop equipment/technologies and develop the required data and validation packages to support these technologies in a GMP environment.
- Develop business processes, guidelines, SOPs (Standard Operating Procedures), and training for processing equipment and technologies.
- Build the equipment maintenance & life cycle plans to support the equipment deployed in the manufacturing network.
- Partner with Site MSAT Manufacturing Technology & Science teams on global and site objectives.
- Provide subject matter expert support in Non-Conformance investigation, CAPAs and provide process impact evaluations of equipment issues.
Benefits
- Comprehensive benefits to include Medical, Dental and Vision
- Short-term and long-term disability
- Company paid basic life insurance
- 401k company match
- Flexible work
- Generous paid time off and paid holiday
- Wellness and transportation benefits
- Discretionary annual bonus
