Materials Process Engineer II — Single-Use Tech & Validation

Evotec WD; Redmond (WA); On-site; USD 80,000 - 92,000; Full time

Benefits offered by this job

Discretionary annual bonus

Medical, Dental and Vision insurance

Short-term & long-term disability

Company paid basic life insurance

401k company match

Flexible work

Generous PTO and holidays

Wellness and transportation benefits

Job summary

Evotec Biologics in Redmond, WA is seeking a Materials Process Engineer II to drive design, development and procurement of single-use instrumentation for the global manufacturing network. You will support validation, vendor qualification, and NC/CAPA investigations, contributing to scalable biotherapeutics production.

The role emphasizes problem-solving, cross-functional teamwork, and continuous improvement within the MSAT and Manufacturing Operations groups.

Qualifications

• 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 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.

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 feasibility and justification for creating the component or using the instrumentation.
• Assist project leads 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.

Skills

Strong communication

Analytical thinking

Collaboration

Education

BS in engineering

MS degree (advantage)

Tools

Single-use disposable systems

Autoclave systems

Job description

Evotec Biologics in Redmond, WA is seeking a Materials Process Engineer II to drive design, development and procurement of single-use instrumentation for the global manufacturing network. You will support validation, vendor qualification, and NC/CAPA investigations, contributing to scalable biotherapeutics production.

The role emphasizes problem-solving, cross-functional teamwork, and continuous improvement within the MSAT and Manufacturing Operations groups.