Process Engineer II - Site Based, Redmond, WA

Evotec•Redmond, WA

10h•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 in the role of Process Engineer II as part of the GMSAT Process Engineering Team will support the design, development and procurement of new equipment and technologies for the Just-Evotec manufacturing network. The role will develop the support testing of the technology, documentation for validation and implantation of the technology, 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 for both Just-Evotec sites and client sites, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections.

Requirements

BS in engineering, sciences, or related life science engineering
2-5 years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or an MS degree.
Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals.
Solid understanding of monoclonal antibody processing either at manufacturing scale or in process development.
Experience working with single-use disposable manufacturing systems.
Demonstrated ability to work independently and collaboratively on cross-functional teams.
Working knowledge of manufacturing process equipment and automation systems.
Candidate must focus on quality, attention to detail, and effective task/time management organizational skills.
Ability to organize, analyze/interpret, and effectively communicate process data.
Excellent oral and written communication skills.

Nice To Haves

Practical experience or knowledge working with continuous manufacturing processes.
Experience using DeltaV automation
Participation in global teams, Center of Excellence, etc.
Applies knowledge and expertise to solve complex technical problems.
Proficiency developing and executing commissioning/qualification (CQV) plans and protocols
Can work independently and in project teams; May lead projects within functional area expertise at Just Evotec Biologics .

Responsibilities

Work with key stakeholders to evaluate new and existing technologies to increase efficiency and facility throughput.
Develop design documents (user requirement specifications, software functional specifications) based on platform process requirements and validation commissioning and qualification protocols.
Assist project leads and automation team with integrating equipment and technologies into the Distribute Control System (DCS) with the manufacturing suite.
Evaluate single-use technologies and design single-use manifolds and assemblies .
Work with vendors to develop data and validation packages supporting technologies.
Facilitate procurement and implementation of approved new technologies.
Develop business processes, guidelines, SOPs, and training for processing equipment and technologies.
Lead the development equipment maintenance & life cycle plans
Partner with Site MSAT Manufacturing Technology & Science teams on global and site objectives.
Participate in non-conformance/deviation investigation and provide process impact evaluations of equipment issues.
Participate in exchange of technical problems and solutions throughout the manufacturing network.
Participate in internal and external audits/inspections.