Senior Biotech Process Engineer — Tech Innovation & Scale-Up

Evotec SE; Redmond (WA); On-site; USD 134,000 - 154,000; Full time

Job summary

Just-Evotec Biologics in Redmond, WA seeks a Principal Process Engineer to lead the design and development of new equipment and single-use technologies for the manufacturing network. The role drives cross-functional evaluations, prepares validation and regulatory documentation, and supports global processing platforms.

The successful candidate will guide global design documents, work with automation on DCS integration, and partner with Site MSAT Manufacturing Technology & Science teams to

Qualifications

• BS in engineering, sciences, or related life science engineering with 12+ years of relevant experience.
• SME knowledge in cell culture biopharmaceutical manufacturing, chromatography, filtration operations, viral clearance, and drug substance formulation.
• Understanding of upstream cell culture expansion and processing operations, including perfusion processing.
• Experience designing and developing GMP single-use instrumentation and assemblies; knowledge of Leachable & Extractables programs.
• Experience leading technology implementation and validation activities for clinical and commercial manufacturing readiness.
• Experience executing facility fit assessments and process validation activities.
• Ability to work independently and lead cross-functional teams.
• Attention to quality, attention to detail, and effective task/time management.
• Ability to organize, analyze/interpret, and present data to senior leadership.

Responsibilities

• 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.

Skills

Cell culture biopharmaceuticals

Chromatography

Filtration operations

Viral clearance

Drug substance formulation design

Upstream cell culture processing

Single-use instrumentation design

Leachable & Extractables

GMP equipment

Technology implementation & validation

CQV/commissioning/qualification

Data analysis & presentation

Project leadership

Education

BS in engineering or life sciences

MS in engineering or life sciences

Job description

Just-Evotec Biologics in Redmond, WA seeks a Principal Process Engineer to lead the design and development of new equipment and single-use technologies for the manufacturing network. The role drives cross-functional evaluations, prepares validation and regulatory documentation, and supports global processing platforms.

The successful candidate will guide global design documents, work with automation on DCS integration, and partner with Site MSAT Manufacturing Technology & Science teams to