Process Engineer II - Downstream - Site Based, Redmond, WA

Posted 4 Days Ago
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2 Locations
In-Office
80K-90K Annually
Mid level
Biotech • Pharmaceutical
The Role
Support downstream cGMP manufacturing for clinical-scale continuous processing trains. Serve as site MSAT SME on projects, author and manage process documentation and change controls, lead investigations and CAPA implementation, analyze process performance, provide 24/7 on-call production support, and drive continuous improvement and risk management using Quality by Design principles.
Summary Generated by Built In

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

The Role:

We’re looking for a passionate and curious Process Engineer II 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 II 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 II 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.

Roles and 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 change controls including managing change implementation of the change as the assigned change agent.

  • 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.

  • Monitors and reports on process performance data analysis.

  • Ability to share 24/7 on call support activities during production.

  • Apply Operational Excellence principles to lead continuous improvement for downstream process improvements.

Position Requirements:

  • Masters (or Bachelors) degree in Engineering with 2+ (5+) years of pharmaceutical/biotech experience including a minimum of 2-4 years of supporting downstream purification activities for biopharmaceutical products.

  • 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.

  • 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.

  • Experience in leading risk assessment and risk management for pharmaceutical products and processes.  Experience in applying principles of Quality by Design.

The base pay range for this exempt position at commencement of employment is expected to be $80,000 to $90,000;  Base salary offered may vary depending on the individual’s 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.

Skills Required

  • Master's or Bachelor's degree in Engineering
  • 2-4+ years supporting downstream purification activities for biopharmaceutical products
  • Proven experience working in GMP pharmaceutical or biotechnology environments
  • Experience with downstream purification and solution preparation using disposable-based manufacturing technologies
  • Experience authoring and reviewing process documentation, SOPs, batch records, and test protocols
  • Experience leading investigations, change controls, CAPA implementation, and process performance analysis
  • Experience in risk assessment/risk management and applying Quality by Design principles
  • Strong interpersonal, written and verbal communication skills and ability to influence stakeholders
  • Ability to participate in 24/7 on-call production support
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The Company
HQ: Hamburg
5,042 Employees

What We Do

Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients. Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing. We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI. We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.

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