Just Evotec Biologics
Biotech
ProcessEngineerIII
Neural analysis suggests this role is
optimal for Senior candidates.
“Process Engineer III at Just Evotec Biologics. Skills: Process Engineering, Technology Implementation, Validation, cGMP Manufacturing, Single-Use Technologies. lead the design, development and procurement of new equipment and technologies. lead the testing of the technology”
What You'll Achieve.
increase efficiency and facility throughput
Industry & Context.
find creative solutions; lead non-conformance/deviation investigations and provide process impact evaluations of equipment/technology issues; lead technical exchanges problems and solutions; Applies knowledge and expertise to solve complex technical problems
Site Based, Redmond
What They're Looking For.
Must Have
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, 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, 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, May lead projects within functional area expertise
What You'll Do.
development and procurement of new equipment and technologies
lead the testing of the technology
develop documentation to support validation and implantation of the technology
provide technical and operational support
provide person-in-plant support
lead cross functional groups to generate regulatory submission documentation
provide support for regulatory and site 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 Distribute 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
and training for processing equipment and technologies
Lead the development equipment maintenance & 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
How You'll Work.
Team & Collaboration
Work with key stakeholders; Collaborate with the automation team; Demonstrated ability to work independently and collaboratively on cross-functional teams; Lead cross functional groups; Lead technical exchanges problems and solutions throughout the manufacturing network; Participation in global teams, Center of Excellence, etc.
Communication Scope
Excellent oral and written communication skills; Ability to organize, analyze/interpret, and effectively communicate process data
Process & Methodology
Leading technology implementation, May 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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