Principal Process Engineer, MSAT

Job title: Principal Process Engineer

Location: Redmond, WA

Reports to: Director, Technical Operations

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!

As a Principal Process Engineer on our Global MSAT Process Engineering team, you’ll play a leading role in shaping the equipment, technologies, and single-use solutions used across the Just-Evotec Biologics manufacturing network.

This position provides an opportunity to operate as a technical leader and subject matter expert, partnering across MSAT, Manufacturing, Automation, Engineering, and external technology vendors to evaluate, develop, and implement innovative solutions that improve manufacturing efficiency, reliability, and facility throughput.

You’ll lead cross-functional technology evaluations, develop global design and implementation strategies, and help advance new technologies from concept and testing through qualification and GMP manufacturing readiness. You’ll also provide technical and operational support to Site MSAT and Manufacturing Operations teams across the network.

The role will provide in-plant support, contribute to regulatory submission documentation, and support regulatory and site inspections.

• Lead the evaluation, design, development, and implementation of new and existing manufacturing technologies across the Just-Evotec Biologics 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 Automation on the design and development of Distributed Control Systems (DCS) and integration of PLC-based equipment.
• Provide technical leadership for facility fit assessments, utility requirements, equipment layouts, and associated Commissioning, Qualification, and Validation (CQV) activities.
• Evaluate and advance single-use technologies, instrumentation, manifolds, and assemblies for use within the manufacturing platform.
• 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.

• 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.
• Demonstrated…