Process Engineer III, MSAT

Evotec SE; Redmond (WA); On-site; USD 92,000 - 127,000; Full time

Job summary

Just-Evotec Biologics is seeking a Process Engineer III in Redmond, WA to lead the design, development and deployment of new equipment and technologies across the manufacturing network.

You will collaborate with MSAT, manufacturing operations, and vendors to evaluate technologies, develop documents, support validation, and prepare regulatory submissions; strong cGMP knowledge and experience with single-use systems are essential.

Qualifications

• BS in engineering or life sciences with 5+ years in pharma/biotech or MS with 2+ years
• Subject matter expert in single-use processing equipment and technologies
• Experience leading technology implementation and validation activities for clinical and commercial manufacturing
• Working knowledge of cGMP regulations for biologics/pharmaceuticals
• Understanding monoclonal antibody processing at manufacturing scale
• Experience with single-use disposable systems
• Strong communication and cross-functional collaboration
• Ability to organize, analyze and interpret process data

Responsibilities

• Evaluate new technologies with stakeholders to improve throughput
• Develop design documents based on platform requirements and CQV protocols
• Collaborate with automation on DCS design for manufacturing suite
• Lead technology evaluation of single-use systems
• Develop data and validation packages with vendors
• Facilitate procurement and implementation of new tech
• Develop SOPs and training for equipment and technologies
• Lead maintenance and lifecycle planning
• Lead non-conformance investigations and assess process impact
• Support audits/inspections and regulatory submissions

Skills

Single-use systems

cGMP knowledge

Biopharma manufacturing

Cross-functional teamwork

Process data analysis

Education

BS in engineering or related life sciences

MS in engineering or related life sciences

Tools

DeltaV automation

Job description

Job Title: Process Engineer III

Location: Redmond, WA
Reports To: Director, Global MSAT

About Us:

At Just-Evotec Biologics, 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? #BeCureious with us and see where your curiosity can take you!

The Role:

As a Process Engineer III 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.

The selected candidate in the role of Process Engineer III as part of the GMSAT Process Engineering Team will lead the design, development and procurement of new equipment and technologies for the Just-Evotec manufacturing network working closely with key stakeholders. The role will lead the testing of the technology, develop documentation to support validation and implantation of the technology, and provide technical and operational support to Just-Evotec's Site MSAT and Manufacturing Operations groups. The role may also provide person-in-plant support for both Just-Evotec sites and client sites, lead cross functional groups to generate regulatory submission documentation, and provide support for regulatory and site inspections.

What You'll Do:

• Work with key stakeholders and vendors to evaluate new technologies for implantation into the manufacturing process 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
• Collaborate with the automation team on design and development of the Distribute Control System (DCS) with the manufacturing suite.
• Support technical evaluations of the facility utility requirements.
• Lead evaluation of 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 equipment maintenance & life cycle plans.
• Lead non-conformance/deviation investigations and provide process impact evaluations of equipment/technology issues.
• Lead technical exchanges problems and solutions throughout the manufacturing network.
• Participate in internal and external audits/inspections.

Who You Are:

• BS in engineering, sciences, or related life science engineering 5+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 2+ years of experience.
• Considered a subject matter expert in biopharmaceutical manufacturing single-use processing equipment and technologies
• Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readiness
• 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 and organizational skills.
• Ability to organize, analyze/interpret, and effectively communicate process data.
• Excellent oral and written communication skills.

Additional Preferred Qualifications:

• Experience working with continuous manufacturing processes, leading newer engineers and 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.

Why Join Us:

• Growth Opportunities: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow.
• Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged.
• Innovative Projects: You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We don't just talk about thinking outside the box, we throw the box away. If you've got ideas, we want to hear them.

Are You Still Curious?

If you've read this far, then chances are you've got a curious mind, just like us. So, what are you waiting for? We can't wait to see where your curiosity leads you and how it will shape the future of Just-Evotec Biologics.

The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; Base salary offered may vary depending on individual's skills, experience and competitive market value.

• discretionary annual bonus