Principal Process Engineer

Evotec; Redmond (WA); On-site; USD 90,000 - 120,000; Full time

Job summary

Evotec in Redmond, WA seeks a Principal Process Engineer to lead the design and development of new equipment and technologies for biomanufacturing. This role will collaborate with various stakeholders to optimize and support the implementation of innovative manufacturing processes.

The ideal candidate will have strong experience in biomanufacturing, regulatory compliance, and cross-functional evaluations. Join us in innovating better access to biotherapeutics.

Qualifications

• Strong understanding of biomanufacturing platforms and equipment.
• Experience with regulatory submissions and site inspections.
• Ability to lead cross-functional evaluations of technologies.

Responsibilities

• Develop strategies for new and existing technologies.
• Support innovative technology evaluation and approval processes.
• Collaborate with automation team for DCS integration.
• Support facility utility requirement evaluations and CQV activities.

Skills

Biomanufacturing optimization

Cross-functional collaboration

GMP equipment management

Technical documentation

Job description

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.

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.