Process Engineer III, MSAT

Evote; Union Hill-Novelty Hill (WA); On-site; USD 92,000 - 127,000; Full time

Benefits offered by this job

Comprehensive benefits

401k match

Flexible work

Paid time off

Wellness benefits

Transportation benefits

Job summary

Just-Evotec Biologics is seeking a Process Engineer III to join the Global MSAT Process Engineering team in Redmond, WA. You will bring new equipment and technologies into our biologics manufacturing network, working with Manufacturing, MSAT, Automation, and vendors to evaluate, design, test, procure, and implement solutions.

You will develop documentation for qualification and validation, support regulatory submissions, audits, and site inspections, and help shape how new technologies are

Qualifications

• BS in engineering, sciences, or related life science engineering; 5+ years in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 2+ years.
• Strong knowledge of single-use processing equipment used in biopharmaceutical manufacturing.
• Experience leading technology implementation and validation activities for clinical and commercial manufacturing readiness.
• Working knowledge of cGMP manufacturing and regulatory requirements for biologics/pharmaceuticals.
• Solid understanding of monoclonal antibody processing at manufacturing scale or process development.
• Experience with single-use disposable manufacturing systems.
• Demonstrated ability to work independently and on cross-functional teams.
• Working knowledge of manufacturing process equipment and automation systems.
• Focus on quality, attention to detail, and effective task/time management.
• Ability to organize, analyze/interpret, and communicate process data.
• Excellent oral and written communication skills.

Responsibilities

• Partner with stakeholders and vendors to evaluate and implement new manufacturing technologies.
• Develop URS and FS to support qualification and validation requirements.
• Collaborate on DCS design and integration with manufacturing equipment.
• Support evaluations of facility and utility requirements for equipment.
• Lead evaluation of single-use technologies and manifolds.
• Work with vendors to develop testing data and validation packages.
• Support procurement, implementation, qualification, and lifecycle management of technologies.
• Develop SOPs, training materials, and maintenance plans.
• Lead investigations of non-conformance and deviations and assess process impact.
• Share knowledge across the manufacturing network.
• Participate in audits and regulatory inspections as needed.

Skills

Single-use equipment

Cross-functional teamwork

Regulatory compliance

Process data analysis

Excellent communication

Education

BS in engineering or life sciences

Tools

DeltaV automation

DCS integration

URS/FS documentation

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? #BeCurious with us and see where your curiosity can take you!

The Role:

As a Process Engineer III on our Global MSAT Process Engineering team, you’ll play an important role in bringing new equipment and innovative technologies into our biologics manufacturing network.

You’ll work cross-functionally with Manufacturing, MSAT, Automation, external vendors, and other key stakeholders to evaluate, design, test, procure, and implement new manufacturing technologies. You’ll also develop documentation supporting qualification and validation activities and provide technical and operational support across the Just-Evotec manufacturing network.

This role offers the opportunity to take ownership of technical projects, solve complex manufacturing challenges, and help shape how new technologies are implemented in a GMP biologics environment.

The role will also provide support at Just-Evotec and client sites, contribute to regulatory submission documentation, and support regulatory and site inspections.

What You'll Do:

• Partner with key stakeholders and vendors to evaluate and implement new manufacturing technologies that improve efficiency and facility throughput.
• Develop technical design documentation, including User Requirement Specifications (URS) and software functional specifications, to support process, commissioning, qualification, and validation requirements.
• Collaborate with Automation on the design and development of Distributed Control Systems (DCS) and integration with manufacturing equipment.
• Support technical evaluations of facility and utility requirements for manufacturing equipment and technologies.
• Lead the evaluation of single-use technologies, including the design of single-use manifolds and assemblies.
• Partner with vendors to develop testing data and validation packages supporting new equipment and technologies.
• Support the procurement, implementation, qualification, and lifecycle management of approved manufacturing technologies.
• Develop business processes, guidelines, SOPs, training materials, and equipment maintenance and lifecycle plans.
• Lead or support non-conformance and deviation investigations and assess the process impact of equipment and technology-related issues.
• Facilitate the exchange of technical knowledge, challenges, and solutions across the manufacturing network.
• Participate in internal and external audits and regulatory inspections, as needed.

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.
• Strong knowledge of single-use processing equipment and technologies used in biopharmaceutical manufacturing.
• 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 within 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 with continuous manufacturing processes, DeltaV automation, and/or mentoring or guiding less-experienced engineers.
• Experience developing and executing Commissioning, Qualification, and Validation (CQV) plans and protocols.
• Can work independently and in project teams.

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.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at 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. Additional total rewards include discretionary annual bonus, 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.

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.