Process Engineer III, Global MSAT

Evotec SE; Redmond (WA); Presencial; USD 92.000 - 127.000; Jornada completa

Descripción de la vacante

Just-Evotec Biologics in Redmond, WA seeks a Process Engineer III to drive new equipment and technology adoption across the GMP biologics network. You will work with Manufacturing, MSAT, Automation, and vendors to bring innovations from concept to qualification.

You’ll own technical projects, develop validation plans, and support regulatory submissions while ensuring manufacturing readiness at both Just-Evotec and client sites.

Formación

• BS in engineering, sciences, or related life science engineering; 5+ years in Pharma/Biotech or MS with 2+ years.
• Experience with single-use processing equipment and technologies.
• Knowledge of process validation and regulatory expectations for biologics.
• Strong problem-solving and data interpretation skills.

Responsabilidades

• Partner with stakeholders and vendors to evaluate and implement new manufacturing technologies.
• Develop URS and software specs to support qualification and validation.
• Collaborate with Automation on DCS design and integration with equipment.
• Support facility and utility requirement evaluations for equipment.
• Lead evaluation of single-use manifolds and assemblies.
• Develop testing data and validation packages with vendors.
• Support procurement, qualification, and lifecycle management of technologies.
• Create SOPs, training materials, and maintenance plans.
• Lead or assist investigations of deviations and non-conformances.
• Share knowledge across the manufacturing network and participate in audits.

Conocimientos

Single-use processing

Cross-functional teamwork

cGMP knowledge

Regulatory knowledge

Data analysis

Communication

Educación

BS in engineering / sciences / related life science

MS in engineering / life sciences

Herramientas

DeltaV automation

DCS design

Automation systems

Descripción del empleo

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 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 andorganizational 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.

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.