Just Evotec Biologics
Biotech
ProcessEngineerIII
Neural analysis suggests this role is
optimal for Mid candidates.
“Process Engineer III at Just Evotec Biologics. Skills: Process Engineering, Single-use technologies, cGMP manufacturing, Validation. Lead design, development, procurement of new equipment. Lead testing of technology”
What You'll Achieve.
Increase efficiency; Increase facility throughput; Manufacturing readiness; Support regulatory and site inspections
Industry & Context.
Ask the hard questions; Find creative solutions; Lead non-conformance/deviation investigations; Provide process impact evaluations; Lead technical exchanges problems and solutions; Solve complex technical problems
Site Based, Person-in-plant support for both Just-Evotec sites and client sites
What They're Looking For.
Must Have
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, Leading technology implementation and validation activities for clinical and commercial manufacturing readiness, Working knowledge of cGMP manufacturing and 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
Nice to Have
Experience working with continuous manufacturing processes, Leading newer engineers, Using DeltaV automation, Participation in global teams, Center of Excellence, 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, May lead projects within functional area expertise
What You'll Do.
procurement of new equipment
Lead testing of technology
Develop documentation for validation
Provide technical support
Provide operational support
Provide person-in-plant support
Lead cross functional groups
Generate regulatory submission documentation
Support regulatory inspections
Evaluate new technologies
Develop design documents
Collaborate with automation team
Support facility utility requirements
Lead evaluation of single-use technologies
Design single-use manifolds
Design single-use assemblies
Develop data packages
Facilitate procurement
Facilitate implementation
Develop business processes
Lead equipment maintenance plans
Lead life cycle plans
Lead deviation investigations
Provide process impact evaluations
Lead technical exchanges
Participate in audits
Participate in inspections
How You'll Work.
Team & Collaboration
Work closely with key stakeholders; Collaborate with the automation team; Work with vendors; Work with cross-functional teams; Participate in global teams; Work in Center of Excellence
Communication Scope
Excellent oral and written communication skills; Effectively communicate process data
Process & Methodology
Lead technology implementation, Lead evaluation of single-use technologies, Facilitate procurement, Facilitate implementation, Lead equipment maintenance plans, Lead life cycle plans, Lead deviation investigations, Lead technical exchanges, Lead projects within functional area expertise
Full Job Description
**Job Title:** Process Engineer III **Location:** Redmond, WA **Department:** Global MSAT **Reports To:** Director, GMSAT **About Us: this is who we are** At **Just** **Evotec Biologics** , we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? **#BeCureious** with us and see where your curiosity can take you! **The Role: / your challenge, …in our journey** As a Process Engineer III at **Just** **Evotec Biologics** , you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team. The selected candidate in the role of Process Engineer III as part of the GMSAT Process Engineering Team will lead the design, development and procurement of new equipment and technologies for the Just-Evotec manufacturing network working closely with key stakeholders. The role will lead the testing of the technology, develop documentation to support validation and implantation of the technology, and provide technical and operational support to Just-Evotec’s Site MSAT and Manufacturing Operations groups. The role may also provide person-in-plant support for both Just-Evotec sites and client sites, lead cross functional groups to generate regulatory submission documentation, and provide support for regulatory and site inspections. **Responsibilities (including but are not limited to):** * 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 specification
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