Principal Process Engineer

Job Title:

Principal Process Engineer.

Location:

Redmond, WA.

Reports to:

Director, Technical Operations.

• Develop strategies for the design and development of new and existing technologies across the Just‑Evotec Biological Manufacturing network.
• Build and maintain 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.
• Develop global 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 and integration of PLC‑based systems into the DCS.
• Support technical evaluations of the facility utility requirements, layouts within the manufacturing area and associated CQV 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, 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 with 12+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 10+ years of experience.
• SME knowledge in cell culture biopharmaceutical manufacturing, specifically around chromatography, filtration operations, viral clearance and drug substance formulation design and operations.
• Understanding of upstream cell culture expansion and processing operations, including perfusion processing.
• Experience designing and developing GMP single‑use instrumentation and assemblies with knowledge of leachable & extractables programs.
• 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 inform senior leadership.

• Experience developing and providing oversight to continuous process monitoring and manufacturing strategies.
• Experience using Delta
  
  V automation to control both PLC‑based and non‑PLC‑based equipment.
• Participation in global teams, Center of Excellence, etc.
• Applies knowledge and expertise to solve complex technical problems.
• Proficiency in diagnosing and executing commissioning/qualification plans and protocols.
• Ability to work independently and in project teams; may lead cross‑functional projects.

• Base pay range: $134,000 to $154,100.
• Discretionary annual bonus.
• Comprehensive benefits including medical, dental, and vision coverage.
• Short‑term and long‑term disability.
• Company‑paid basic life insurance.
• 401(k) company match.
• Flexible work arrangements.
• Generous paid time off and paid holidays.
• 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.