Assistant Quality Process Engineer Jobs in Seattle, WA

Job Title: Process Engineer II

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

About Us: this is who we are

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:

We're looking for a passionate and curious Process Engineer II 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 II 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.

Just-Evotec Biologics is seeking a motivated and creative Process Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics.

The selected candidate in the role of Process Engineer II as part of the GMSAT Process Engineering Team will support the design, development and procurement of new equipment and technologies for the Just-Evotec manufacturing network. The role will develop the support testing of the technology, documentation for 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, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections.

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.

• Assist 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 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.

Position Requirements:

• BS in engineering, sciences, or related life science engineering 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.

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

• Excellent oral and written communication skills.

Additional 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.

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? 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 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 $83,000 to $86,250; 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.