Process Engineer III, Global MSAT

Job Title: Process Engineer III

Location: Redmond, WA

Reports To: Director, Global MSAT

As a Process Engineer III at Just-Evotec Biologics, you will lead the design, development and procurement of new equipment and technologies for the manufacturing network, working closely with key stakeholders. You will conduct testing, develop supporting documentation for validation and implementation, provide technical and operational support to site MSAT and Manufacturing Operations groups, and may offer person‑in‑plant support and lead cross‑functional groups for regulatory submissions and inspections.

• Work with key stakeholders and vendors to evaluate new technologies for implantation into the manufacturing process to increase efficiency and facility throughput.
• Develop design documents (user requirement specifications, software functional specifications) based on platform process requirements and validation commissioning and qualification protocols.
• Collaborate with the automation team on design and development of the Distributed Control System (DCS) with the manufacturing suite.
• Support technical evaluations of the facility utility requirements.
• Lead evaluation of single‑use technologies and design single‑use manifolds and assemblies.
• Work with vendors to develop data and validation packages supporting technologies.
• Facilitate procurement and implementation of approved new technologies.
• Develop business processes, guidelines, SOPs, and training for processing equipment and technologies.
• Lead the development of equipment maintenance and life‑cycle plans.
• Lead non‑conformance/deviation investigations and provide process impact evaluations of equipment/technology issues.
• Lead technical exchanges, problems, and solutions throughout the manufacturing network.
• Participate in internal and external audits/inspections.

• BS in engineering, sciences, or related life science engineering with 5+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 2+ years of experience.
• Subject matter expert in biopharmaceutical manufacturing single‑use processing equipment and technologies.
• Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readiness.
• Working knowledge of cGMP manufacturing, regulatory regulations, and requirements for biologics/pharmaceuticals.
• Solid understanding of monoclonal antibody processing either at manufacturing scale or in 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.
• 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.

• Experience with continuous manufacturing processes, leading newer engineers, and using Delta
  
  V automation.
• Participation in global teams, Center of Excellence, etc.
• Applies knowledge and expertise to solve complex technical problems.
• Proficiency developing and executing commissioning/qualification (CQV) plans and protocols.
• Can work independently and in project teams; may lead projects within functional area expertise at Just Evotec Biologics.

The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500;
Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short‑term and long‑term disability, company‑paid basic life insurance, 401(k) company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.