Job Description

Job Title: Process Engineer III, Upstream –Site MSAT

Location: Just Evotec Biologic. – Main based site will be Redmond, WA and travelling to Seattle, WA, covering both sites.

Shifts: Days, Monday to Friday, as required weekend cover, twice per month with some flexibility.

About Us: this is who we are

At Just Evotec Biologic, 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: / your challenge, …in our journey

We’re looking for a passionate and curious Process Engineer III to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a Process Engineer III at Just Evotec Biologic, 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 Process Engineer III Upstream for Site MSAT is part of a fast-paced, collaborative, and multidisciplinary team. The role reports to Upstream Lead for site MSAT, and is responsible to support all aspects of upstream processing for multiple clinical-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations. The role may also be responsible for leading activities related to the introduction of new products in Just-Evotec’s USA manufacturing facilities.

What You’ll Do:

• Promotes a culture of safety

• Represents site MSAT on internal and external project teams as technical subject matter expert (SME) and interfaces with global MSAT, Manufacturing Operations and Quality functions.

• Authors, reviews and approves GMP process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs)

• Leads complicated and multi-disciplinary change controls and will function as a lead for the project team.

• Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions.

• Utilize technical skills and process knowledge to participate and/or lead investigations related to process issues/deviation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.

• Lead quality and technical risk assessment activities.

• Support and/or lead technology transfer or new production introduction activities.

• Provide training and technical knowledge sharing to manufacturing.

• Partner with Validation and Quality groups in supporting equipment onboarding activities and periodic review programs as process owners.

• Support and on-call rotating to support 24/7 operations

• Confident to act as a subject matter expert for regulatory and client inspection audits.

• Apply Operational Excellence principles to lead continuous improvement ideas for manufacturing and technology transfer related activities.

Who You Are:

• Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience including a minimum of 2+ years of supporting upstream cell culture activities for biopharmaceutical products.

• Knowledge and experience CMC stage gates for clinical and commercial biologics drug substance manufacturing programs.

• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.

• Solid understanding of upstream processing including hands on experience in single-use bioreactor operations and perfusion technology either at Manufacturing scale or in process development of biologics.

• Solid understanding of GMP concepts and quality systems necessary to support manufacturing and new production introduction activities.

• Working knowledge of manufacturing process equipment and automation systems

• Experienced deviation investigator and knowledgeable of root cause analysis tools (RCA)

• Possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills.

• Ability to organize, analyze/interpret, and effectively communicate process data.

• Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders

• Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.

Additional Preferred Qualifications:

• Experience in supporting audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.

• Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.

• Entrepreneurial drive to achieve business objectives.

• Experience with Delta V for process control.

• Experience with supporting late-stage manufacturing, technical transfer and process validation studies.

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.

• Flexible Work Environment We offer flexible work options to help you balance your professional and personal life. Site based Redmond, with some travel to our Seattle site required.

• 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? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and how it will shape the future of Just Evotec Biologic

Let your curiosity guide your career— #BeCurious and explore the endless possibilities at Just Evotec Biologic!

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 the 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.