Materials Process Engineer I/II – Manufacturing Technical Operations

About Us

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? Join us and see where your curiosity can take you!

About the Role

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.

Just-Evotec Biologics is seeking a motivated and creative Materials Process Engineer to improve worldwide access to biotherapeutics. The selected candidate will support the design, development, and procurement of single-use instrumentation and assemblies to support the Just-Evotec manufacturing network. The role involves testing materials of construction and design to support processing requirements, expanding the leachable/extractables program for commercialization, creating documentation for validation and vendor implementation, and providing technical support for non-conformance (NC) and corrective and preventive action (CAPA) investigations to the Site MSAT and Manufacturing Operations groups. The role will also evaluate new materials for both autoclaved components and pre-sterilized vendor components.

Responsibilities

• Work with key stakeholders to evaluate new and existing technologies and components to increase efficiency and facility throughput.
• Create qualification documents based on platform process requirements and validation commissioning and qualification protocols.
• Develop assessment, test, and technical reports to determine the feasibility and justification for creating components or using instrumentation.
• Assist project leads in evaluating the fit, form, and function of client processes within the JEB manufacturing platform.
• Work with Process Engineers on designing and manufacturing single-use bags and flow paths for new and existing equipment.
• Collaborate with vendors to develop data and validation packages supporting technologies.
• Facilitate procurement and implementation of approved single-use technologies.
• Lead the development of single-use expiry and life cycle plans.
• Partner with Site MSAT Manufacturing Technology & Science teams on global and site objectives.
• Participate in non-conformance/deviation investigations and provide process impact evaluations of single-use issues.
• Exchange technical problems and solutions throughout the manufacturing network.
• Participate in internal and external audits/inspections.

Requirements

• BS in engineering, sciences, or related life science field; 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.
• 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.
• Excellent oral and written communication skills.

Preferred Qualifications

• 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.

Pay

The base pay range for this position at commencement of employment is expected to be $80,000 to $92,000. Base salary offered may vary depending on individual’s skills, experience, and competitive market value.

Benefits

• Discretionary annual bonus.
• Comprehensive benefits including Medical, Dental, and Vision.
• Short-term and long-term disability.
• Company-paid basic life insurance.
• 401k company match.
• Flexible work arrangements.
• Generous paid time off and paid holidays.
• Wellness and transportation benefits.