Principal Process Engineer

Evotec•Redmond, WA

1d•$134,000 - $154,100•Onsite

About The Position

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.

Requirements

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 implementation and validation activities for clinical and commercial manufacturing readiness.
Experience executing facility fit assessments and process validation activities.
Demonstrated ability to work independently and lead collaborative cross-functional teams.
Candidate must focus on quality, attention to detail, and effective task/time management organizational skills.
Ability to organize, analyze/interpret, and present data and project updates to effectively information senior leadership.

Nice To Haves

Experience developing and providing oversight to continuous process monitoring and manufacturing strategies.
Experience using DeltaV automation to control both PLC based and non-PLC based equipment.
Participation in global teams, Center of Excellence, etc.
Applies knowledge and expertise to solve complex technical problems.
Proficiency in providing technical expertise in developing and executing commissioning/qualification (CQV) plans and protocols.
Can work independently and in project teams; May lead cross functional projects at Just-Evotec utilizing functional area expertise.

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.