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

Evotec; Redmond (WA); On-site; USD 86,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k match

Flexible work

Paid time off

Job summary

Just Evotec Biologic is seeking a passionate Process Engineer II (Downstream) to join the MSAT site in Redmond. You will support downstream purification activities for clinical-scale cGMP manufacturing trains on a 24/7 basis, driving process understanding and continuous improvements.

You'll collaborate with global MSAT, Operations and Quality teams, author technical documents, lead investigations, and contribute to CAPA closure while applying Quality by Design principles in a fast-paced biotech

Qualifications

• Masters or bachelor’s degree in Engineering with 2+ (5+) years of pharma/biotech experience.
• Experience supporting downstream purification activities for biopharmaceutical products.
• Proven GMP pharmaceutical/biotech leadership in a regulated environment.
• Ability to work with high-performing teams and influence internal/external stakeholders.
• Excellent verbal and written English communication.
• Experience leading risk assessment and applying principles of Quality by Design.

Responsibilities

• Represent site MSAT on project teams as SME; interface with global MSAT, Operations and Quality.
• Develop process understanding and expertise in downstream processing.
• Authors, reviews and owns process documentation (tech docs, test protocols, batch records, SOPs).
• Authors, reviews change controls and manages change implementation.
• Lead investigations related to process or new product implementation; drive CAPA from approval to closure.
• Monitor and report on process performance data analysis.
• Provide 24/7 on-call support during production as needed.
• Lead continuous improvement for downstream processes using Operational Excellence.

Skills

GMP experience

Biotech/pharma experience

Team leadership

Communication skills

Risk assessment

Quality by Design

Education

Engineering degree (MS or BS)

Job description

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 $86,250 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.