Process Engineer II - Site , Redmond, WA

Position: Process Engineer II - Site Based, Redmond, WA
Job Title:

Process Engineer II

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

We're looking for a passionate and curious Process Engineer II to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a Process Engineer II 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.

Just-Evotec Biologics is seeking a motivated and creative Process Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics.

The selected candidate in the role of Process Engineer II as part of the GMSAT Process Engineering Team will support the design, development and procurement of new equipment and technologies for the Just-Evotec manufacturing network. The role will develop the support testing of the technology, documentation for 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, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections.

Responsibilities (including but are not limited to):

* Work with key stakeholders to evaluate new and existing technologies 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.

* Assist project leads and automation team with integrating equipment and technologies into the Distribute Control System (DCS) with the manufacturing suite.

* Evaluate 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

* Partner with Site MSAT Manufacturing Technology & Science teams on global and site objectives.

* Participate in non-conformance/deviation investigation and provide process impact evaluations of equipment issues.

* Participate in exchange of technical problems and solutions throughout the manufacturing network.

* Participate in internal and external audits/inspections.

Position Requirements :

* BS in engineering, sciences, or related life science engineering 2-5 years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or an MS degree.

* 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…