Process Engineer III, MSAT

As a Process Engineer III on our Global MSAT Process Engineering team, you’ll play an important role in bringing new equipment and innovative technologies into our biologics manufacturing network.

You’ll work cross-functionally with Manufacturing, MSAT, Automation, external vendors, and other key stakeholders to evaluate, design, test, procure, and implement new manufacturing technologies. You’ll also develop documentation supporting qualification and validation activities and provide technical and operational support across the Just-Evotec manufacturing network.

This role offers the opportunity to take ownership of technical projects, solve complex manufacturing challenges, and help shape how new technologies are implemented in a GMP biologics environment.

The role will also provide support at Just-Evotec and client sites, contribute to regulatory submission documentation, and support regulatory and site inspections.

• ◆Partner with key stakeholders and vendors to evaluate and implement new manufacturing technologies that improve efficiency and facility throughput.
• ◆Develop technical design documentation, including User Requirement Specifications (URS) and software functional specifications, to support process, commissioning, qualification, and validation requirements.
• ◆Collaborate with Automation on the design and development of Distributed Control Systems (DCS) and integration with manufacturing equipment.
• ◆Support technical evaluations of facility and utility

for manufacturing equipment and technologies.

• ✓Lead the evaluation of single-use technologies, including the design of single-use manifolds and assemblies.
• ✓Partner with vendors to develop testing data and validation packages supporting new equipment and technologies.
• ✓Support the procurement, implementation, qualification, and lifecycle management of approved manufacturing technologies.
• ✓Develop business processes, guidelines, SOPs, training materials, and equipment maintenance and lifecycle plans.
• ✓Lead or support non-conformance and deviation investigations and assess the process impact of equipment and technology-related issues.
• ✓Facilitate the exchange of technical knowledge, challenges, and solutions across the manufacturing network.
• ✓Participate in internal and external audits and regulatory inspections, as needed.

• ✓BS in engineering, sciences, or related life science engineering 5+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 2+ years of experience.
• ✓Strong knowledge of single-use processing equipment and technologies used in biopharmaceutical manufacturing.
• ✓Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readiness
• ✓Working knowledge of cGMP manufacturing and regulatory regulations and

for biologics/pharmaceuticals.

• ✓Solid understanding of monoclonal antibody processing, either at manufacturing scale or within process development.
• ✓Experience working with single-use disposable manufacturing systems.
• ✓Demonstrated ability to work independently and collaboratively on cross-functional teams.
• ✓Working knowledge of manufacturing process equipment and automation systems.
• ✓Candidate must focus on quality, attention to detail, and effective task/time management and organizational skills.
• ✓Ability to organize, analyze/interpret, and effectively communicate process data.
• ✓Excellent oral and written communication skills.

Additional

• ✓Experience with continuous manufacturing processes, DeltaV automation, and/or mentoring or guiding less-experienced engineers.
• ✓Experience developing and executing Commissioning, Qualification, and Validation (CQV) plans and protocols.
• ✓Can work independently and in project teams.