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Process Engineer III, Global MSAT

Evotec

Job Information Process Engineer III – Redmond, WA. Reports to Director, Global MSAT. Role Overview The Process Engineer III leads design, development, and procurement of new equipment and technologies for the manufacturing network, working closely with key stakeholders. The role leads technology testing, develops documentation for validation and installation, and provides technical and operational support to Site MSAT and Manufacturing Operations groups. It may also provide person‑in‑plant support for Just‑Evotec sites and client sites, lead cross‑functional groups to generate regulatory submission documentation, and support regulatory and site inspections. Responsibilities 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 of problems and solutions throughout the manufacturing network. Participate in internal and external audits and inspections. Qualifications 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. 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. Knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics and pharmaceuticals. Solid understanding of monoclonal antibody processing at manufacturing scale or in process development. Experience with single‑use disposable manufacturing systems. Demonstrated ability to work independently and collaboratively on cross‑functional teams. Knowledge of manufacturing process equipment and automation systems. Strong 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. Preferred Qualifications Experience with continuous manufacturing processes, leading newer engineers, and using DeltaV automation. Participation in global teams or Centers of Excellence and application of expertise to solve complex technical problems. Proficiency in developing and executing commissioning and qualification (CQV) plans and protocols. Ability to work independently and in project teams, and potential to lead projects within functional area expertise. Compensation and Benefits Base pay range: $92,400 to $126,500. Additional total rewards include discretionary annual bonus, comprehensive medical, dental, and vision coverage, short‑term and long‑term disability, company‑paid basic life insurance, 401(k) company match, flexible work, generous paid time off, paid holidays, wellness and transportation benefits. Equal Opportunity Employer 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. #J-18808-Ljbffr Evotec

Vacancy posted 2 days ago
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