Upstream Process Engineer II

About the role

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 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! We're looking for a passionate and curious Upstream Process Engineer II to join our team. If you're excited by new challenges, solving complex upstream 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 bioreactor and cell culture improvements, collaborate with bright minds, and explore uncharted territories. As an Upstream Process Engineer II at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative cell culture and production 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 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.

Responsibilities

• 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.

Requirements

• 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 : 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

Benefits

Additional Information

Job Title: Upstream Process Engineer II Location: Redmond, WA Reports to: Senior Manager, Upstream Process Engineering

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