Process Engineer II

About the role

We are seeking a Process Engineer II to join our team at Just Evotec Biologics in Redmond, WA. This role reports to the Director, Global MSAT.

Responsibilities

• Work with key stakeholders to evaluate new and existing technologies to increase efficiency and facility throughput.
• Develop design documents (user requirement specifications, software functional specifications) based on platform process requirements and validation commissioning and qualification protocols.
• Aid project leads and automation team with integrating equipment and technologies into the Distribute Control System (DCS) with the manufacturing suite.
• Evaluate single-use technologies and design single-use manifolds and assemblies.
• Work with vendors to develop data and validation packages supporting technologies.
• Facilitate procurement and implementation of approved new technologies.
• Develop business processes, guidelines, SOPs, and training for processing equipment and technologies.
• Lead the development of equipment maintenance & 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 equipment issues.
• Participate in exchange of technical problems and solutions throughout the manufacturing network.
• Participate in internal and external audits/inspections.

Requirements

• BS in engineering, sciences, or related life science engineering or MS degree.
• 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 either at manufacturing scale or in process development.
• Experience working with single-use disposable manufacturing systems.
• Demonstrated ability to work independently and collaboratively on cross-functional teams.
• Working knowledge of manufacturing process equipment and automation systems.
• Candidate must focus on quality, attention to detail, and effective task/time management organizational skills.
• Excellent oral and written communication skills.

Preferred Qualifications

• Practical experience or knowledge working with continuous manufacturing processes.
• Experience using DeltaV automation.
• 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.
• Can work independently and in project teams; May lead projects within functional area expertise at Just Evotec Biologics.

Pay

The base pay range for this position at commencement of employment is expected to be $83,000 to $86,250; Base salary offered may vary depending on individual's skills, experience and competitive market value.

Benefits

• Comprehensive benefits to include Medical, Dental and Vision.
• Short-term and long-term disability, company paid basic life insurance.
• 401k company match.
• Flexible work, generous paid time off and paid holiday.
• Wellness and transportation benefits.

Equal Opportunity Employer

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.