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

Overview

Job Title: Process Engineer III, Downstream–Site MSAT

Location: Just Evotec Biologic. – Redmond, WA and Seattle, WA - Covering both site.

Shifts: All days, Monday to Friday, with flexible as required weekend cover.

About Us: this is who we are

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? #Be Cureious with us and see where your curiosity can take you!

The Role: / your challenge, …in our journey

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.

• 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.

• 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.

• Expe…