Materials Process Engineer II, Biotech Manufacturing

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

Benefits offered by this job

Medical, Dental and Vision

Short-term and long-term disability

Company paid life insurance

401k company match

Flexible work

Paid time off

Paid holidays

Wellness benefits

Transportation benefits

Job summary

Evotec (US) Inc. in Redmond, WA is seeking a Materials Process Engineer II to join the GMSAT Process Engineering Team.

You will support the design, development, and procurement of single-use instrumentation and assemblies for our bioprocess network, advancing leachable/extractables programs and validation documentation. The role requires a BS or MS in engineering or life sciences, 2–5 years' pharma/biotech experience, and strong knowledge of cGMP.

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 regulations and requirements for biologics/pharmaceuticals.
• Solid understanding of monoclonal antibody processing at manufacturing scale and associated process equipment and manufacturing.

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 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.

Skills

cGMP knowledge

Single-use systems

Cross-functional teamwork

Analytical skills

Quality focus

Education

BS/MS in engineering

Tools

Autoclave systems

CQV tools

Job description

Evotec (US) Inc. in Redmond, WA is seeking a Materials Process Engineer II to join the GMSAT Process Engineering Team.

You will support the design, development, and procurement of single-use instrumentation and assemblies for our bioprocess network, advancing leachable/extractables programs and validation documentation. The role requires a BS or MS in engineering or life sciences, 2–5 years' pharma/biotech experience, and strong knowledge of cGMP.