Principal Process Engineer

Job title: Principal Process Engineer

Location: Redmond, WA

Reports to: Director, Technical Operations

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:

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 for the Principal Process Engineer role as part of the GMSAT Process Engineering team will lead the team responsible for the design and development of new equipment, technologies and single-use materials for the Just-Evotec Biologics manufacturing network. The role will lead cross functional evaluations of technologies to improve and optimize the biomanufacturing platform, develop the support documentation for implantation of the technology into our global processing platform 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, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections.

What You'll Do:

• Develop strategies for the design and development of new and existing technologies across the Just-Evotec Biological Manufacturing network.

• Develop the lifecycle and maintenance management program for GMP equipment and technologies.
• Support the evaluation and approval of innovative technologies within the manufacturing platform through the project governance group.

• Work with key stakeholders and vendors to evaluate innovative technologies for implantation into the manufacturing process to increase efficiency and facility throughput.

• Work with cross functional teams on the development of global 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 and integration of PLC based systems into the DCS.

• Support technical evaluations of the facility utility requirements, layouts within the manufacturing area and support associated CQV (Commissioning, Qualification, and Validation) activities.

• Evaluate single-use technologies for data acquisition and suitability within single-use manifolds and assemblies.

• Work with vendors to test and develop equipment/technologies and develop the required data and validation packages to support these technologies in a GMP environment.

• Develop business processes, guidelines, SOPs (Standard Operating Procedures), and training for processing equipment and technologies.

• Build the equipment maintenance & life cycle plans to support the equipment deployed in the manufacturing network.

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

• Provide subject matter expert support in Non-Conformance investigation, CAPAs and provide process impact evaluations of equipment issues.

Who You Are:

• BS in engineering, sciences, or related life science engineering 12+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 10+ years of experience.

• Possess SME (Subject Matter Expert) knowledge in cell culture biopharmaceutical manufacturing, specifically around chromatography, filtration operations, viral clearance and drug substance formulation design and operations.

• Understanding of upstream cell culture expansion and processing operations, including perfusion processing.

• Experience designing and developing GMP single-use instrumentation and assemblies with knowledge of Leachable & Extractables programs.

• Experienced in leading technology…