Process Engineer III, Global MSAT

Job Title:

Process Engineer III

Location:

Redmond, WA

Reports To:

Director, Global MSAT

About Us:

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:

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.

What You'll Do:

* 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, guidelines, SOPs, 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.

Who You Are:

* 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.

* Considered a 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 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.

* Candidate must 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.

Additional

Preferred Qualifications:

* Experience working with continuous manufacturing processes, leading newer engineers and using Delta

V automation.

*…