Materials Process Engineer I​/II – Manufacturing Technical Operations

Materials Process Engineer

Location:

Redmond, WA

At Just-Evotec, 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.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCurious with us and see where your curiosity can take you!

We're looking for a passionate and curious Materials Process Engineer II to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a Materials Process Engineer II at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It's a role where your curiosity will fuel both your personal growth and the success of the team.

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-Evote'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.

Responsibilities (including but are not limited to):

• 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.

Position 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…