Principal Process Engineer, MSAT

As a Principal Process Engineer on our Global MSAT Process Engineering team, you’ll play a leading role in shaping the equipment, technologies, and single-use solutions used across the Just-Evotec Biologics manufacturing network.

This position provides an opportunity to operate as a technical leader and subject matter expert, partnering across MSAT, Manufacturing, Automation, Engineering, and external technology vendors to evaluate, develop, and implement innovative solutions that improve manufacturing efficiency, reliability, and facility throughput.

You’ll lead cross-functional technology evaluations, develop global design and implementation strategies, and help advance new technologies from concept and testing through qualification and GMP manufacturing readiness. You’ll also provide technical and operational support to Site MSAT and Manufacturing Operations teams across the network.

The role will provide in-plant support, contribute to regulatory submission documentation, and support regulatory and site inspections.

• ◆Lead the evaluation, design, development, and implementation of new and existing manufacturing technologies across the Just-Evotec Biologics 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.
• ◆Work with cross functional teams on the development of global design documents (user requirement specifications, software functional specifications) based on platform process

and validation commissioning and qualification protocols.

• ✓Collaborate with Automation on the design and development of Distributed Control Systems (DCS) and integration of PLC-based equipment.
• ✓Provide technical leadership for facility fit assessments, utility requirements, equipment layouts, and associated Commissioning, Qualification, and Validation (CQV) activities.
• ✓Evaluate and advance single-use technologies, instrumentation, manifolds, and assemblies for use within the manufacturing platform.
• ✓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 .

• ✓BS in engineering, sciences, or related life science engineering 12+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 10+ years of experience.
• ✓Demonstrated technical expertise in biopharmaceutical manufacturing processes and technologies, with strong knowledge of one or more areas such as chromatography, filtration, viral clearance, drug substance formulation, or upstream processing.
• ✓Understanding of upstream cell culture expansion and processing operations, including perfusion processing.
• ✓Significant experience with single-use bioprocessing equipment, technologies, instrumentation, and/or assemblies.
• ✓Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readiness.
• ✓Experience executing facility fit assessments and process validation activities.
• ✓Demonstrated ability to work independently and lead collaborative cross-functional teams.
• ✓Candidate must focus on quality, attention to detail, and effective task/time management organizational skills.
• ✓Ability to organize, analyze/interpret, and present data and project updates to effectively information senior leadership.

Additional

• ✓Experience with upstream processing, including cell culture expansion and/or perfusion processing.
• ✓Experience with DeltaV automation and the integration of PLC-based and non-PLC-based manufacturing equipment.
• ✓Participation in global teams, Center of Excellence, etc.
• ✓Applies knowledge and expertise to solve complex technical problems.
• ✓Experience developing and executing CQV plans and protocols.
• ✓Can work independently and in project teams; May lead cross functional projects at Just-Evotec utilizing functional area expertise.