Upstream Process Engineer II

Job Title: Upstream Process Engineer II

Location: Redmond WA
Reports to: Senior Manager Upstream Process Engineering

About Us:

At Just-Evotec 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 whats possible. Were on a mission to create a place where curiosity isnt just encouraged its celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper#BeCureious with us and see where your curiosity can take you!

The Role:

Were looking for a passionate and curious Upstream Process Engineer II to join our team. If youre excited by new challenges solving complex upstream problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful bioreactor and cell culture improvements collaborate with bright minds and explore uncharted territories.

As an Upstream Process Engineer II at Just-Evotec youll have the freedom to ask the hard questions think outside the box and find creative cell culture and production solutions that push us forward. Its 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 Upstream Process Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics.The role reports to the Upstream Senior Manager for Site MSAT and is responsible for supporting upstream processing for multiple clinical-scale cGMP manufacturing trains.

What Youll Do:

• Represents Site MSAT on project teams as technical subject matter expert (SME) and interface with Global MSAT Operations and Quality functions.
• Develop process understanding and expertise.
• Authors reviews and owns process related documentation (technical documents test protocols batch records process descriptions SOPs etc)
• Authors reviews and leads change controls including managing change implementation of the change as the assigned change agent.
• 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/ New product implementation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
• Participate in quality and technical risk assessment activities.
• Support technology transfer or new production introduction activities.
• Monitors and reports on process performance data analysis.
• Partner with Validation and Quality groups in supporting equipment onboarding activities and periodic review programs as process owners.
• Ability to share 24/7 on call support activities during production.
• Apply Operational Excellence principles to lead continuous improvement for upstream process improvements.

Who You Are:

• Bachelors degree in Engineering with 2-4 years of pharmaceutical/biotech experience or a masters degree in engineering with greater than 1 year of experience.
• Experience supporting process transfer / technology transfer projects and teams in the biopharmaceutical industry; commercial manufacturing campaign support is a plus.
• 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 product introduction activities.
• Working knowledge of manufacturing process equipment and automation systems.
• Ability to organize analyze/interpret and effectively communicate process data.
• Must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills.
• Good interpersonal team and collaborative skills are required.
• Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.

Additional Preferred Qualifications:

• Ability to navigate regulatory CMC documents.
• Experience with DeltaV for process control
• Experience with supporting late-stage manufacturing technical transfer and process validation studies.
• Experience in supporting audits and inspections by health authorities clients and other external auditors as a presenter or audit support staff.

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll 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 dont just talk about thinking outside the box we throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mind just like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads you and how it will shape the future of Just-Evotec.

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

The base pay range for this position at commencement of employment is expected to be $86250 to $90000; Base salary offered may vary depending on individuals 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.