Process Engineer III - Site Based, covering Redmond & Seattle, WA

Cyprotex•Redmond, WA

22h•$92,400 - $126,500•Onsite

About The Position

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! 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 Downstream for Site MSAT is part of a fast-paced, collaborative, and multidisciplinary team. The role reports to Downstream Lead for site MSAT, and is responsible to support all aspects of downstream processing for multiple clinical-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.

Requirements

Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience including a minimum of 2+ years of supporting downstream purification 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.
Technical purification and solution preparation operations using disposable-based manufacturing technologies
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
Good interpersonal, team, and collaborative skills are required.

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.

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.
Possesses a deep understanding of downstream processes for the purification of biologics.
Authors, reviews and approves 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 Quality, Validation and Global MSAT to develop and implement process validation and comparability studies leading to successful product registration.
Is confident to act as a subject matter expert for regulatory and client inspection audits.
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.
Facilitates new product introduction by leading make-a-batch sessions and supporting technical training for manufacturing.
Skilled at organizing data to optimize analysis and trending
Experienced investigator and knowledgeable of root cause analysis tools (RCA)
Support and on-call rotating to support 24/7 operations
Apply Operational Excellence principles to lead continuous improvement ideas for downstream manufacturing.