Process Engineer III, Upstream –MSAT, Site Based, Redmond, WA

Cyprotex•Redmond, WA

9d•$92,400 - $126,500•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.