Materials Process Engineer I/II – Manufacturing Technical Operations

Evotec•Redmond, WA

15d•$80,000 - $92,000•Onsite

About The Position

Just-Evotec Biologics is seeking a motivated and creative Materials Process Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The selected candidate in the role of Materials Process Engineer II as part of the GMSAT Process Engineering Team will support the design, development and procurement of single-use instrumentation and assemblies to support the Just-Evotec manufacturing network. The role will develop the support testing of the materials of construction and design to support processing requirements, further development and expansion of the leachable/extractables program to support commercialization, documentation for validation and implantation of vendors and components, and provide technical support for NC and CAPA investigations to the Just-Evotec’s Site MSAT and Manufacturing Operations groups. The role will also provide evaluation of new materials to support both autoclaved components and vendor components that are pre-sterilized.

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 at manufacturing scale and associated process equipment and manufacturing
Experience working with single-use disposable manufacturing systems
Demonstrated ability to work independently and collaboratively on cross-functional teams.
Working knowledge of large-scale autoclave systems
Candidate must focus on quality, attention to detail, and effective task/time management organizational skills.
Ability to organize, analyze/interpret, and effectively communicate investigation data.
Good interpersonal, team, and collaborative skills are a must.
Excellent oral and written communication skills

Nice To Haves

Practical experience or knowledge working with continuous manufacturing processes
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

Responsibilities

Work with key stakeholders to evaluate new and existing technologies components to increase efficiency and facility throughput.
Create qualification documents based on platform process requirements and validation commissioning and qualification protocols.
Create assessment, test and technical reports to determine the feasibility and justification for creating the component or using the instrumentation.
Assist projects lead to evaluate the fit, form and function of the client process within the JEB manufacturing processing platform.
Work with Process Engineers on designing and manufacturing single-use bags and flow paths on new and existing equipment.
Work with vendors to develop data and validation packages supporting technologies.
Facilitate procurement and implementation of approved single-use technologies.
Lead the development single-use expiry & 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 single-use issues.
Participate in exchange of technical problems and solutions throughout the manufacturing network.
Participate in internal and external audits/inspections.