Process Engineer III - Biopharma Tech Transfer (Site-Based)

Evotec; Redmond (WA); On-site; Full time

Job description

Process Engineer III

Shifts: Monday to Friday, Days

Job Overview: The Process Engineer III will support downstream technology transfer of late‑stage biologic molecules, ensuring seamless site‑to‑site transfer, regulatory compliance, and process validation across Just Evotec’s manufacturing network.

Responsibilities

• Support downstream technology transfer of a late‑stage molecule and commercial manufacturing and/or PPQ campaign support.
• Assist site‑to‑site tech transfer activities and perform gap analysis and risk assessments with mitigation plans.
• Build and maintain design spaces (PAR & NOR ranges) for critical process parameters used in validation and support of late‑stage/commercial operations.
• Develop, review, and approve technical documentation, including global protocols for performance qualifications, batch records, and PPQ reports.
• Author templates for Process Validations and Continued Process Verification strategies.
• Conduct analysis of process data, including annual periodic reviews across the network of manufacturing sites.
• Prepare process transfer documents and Process Control strategy for phase III and commercial programs for receiving sites across the Just MFG network.
• Provide in‑plant support, assist in regulatory submissions, and support regulatory and site inspections.

Qualifications

• Bachelor’s degree in engineering, sciences, or related field with 5+ years of relevant experience and 2 years with an MS degree (or equivalent).
• Experience supporting process or technology transfer projects in the biopharmaceutical industry; commercial manufacturing campaign support is a plus.
• Familiar with process risk assessment tools (e.g., FMEA), process modelling, and process trending.
• Understanding of downstream processing, including process chromatography (continuous chromatography), large‑scale column packing, viral filtration, and tangential flow filtration.
• Knowledge of GMP concepts and quality systems required for tech transfer and process validation activities.
• Hands‑on experience with downstream disposable‑based manufacturing technologies from bench‑scale to commercial scale.
• Working knowledge of manufacturing process equipment and automation systems.
• Strong focus on quality, attention to detail, and effective task and time‑management skills.
• Ability to analyze, interpret, and communicate process data clearly.
• Excellent interpersonal, teamwork, and collaborative skills.
• Excellent oral and written communication skills.

Preferred Qualifications

• Practical experience with downstream disposable manufacturing technologies at manufacturing or bench‑scale.
• Ability to apply knowledge to solve complex technical problems.
• Technical resource for downstream manufacturing processes and platforms.
• Capability to work independently and lead projects within functional area expertise.
• Experience navigating global regulatory CMC documents.
• Support for late‑stage manufacturing, tech transfer, and process validation studies.
• Experience with DeltaV for process control.

Benefits

• Growth opportunities, including professional courses and mentorship.
• Flexible work environment with site‑based role.
• Inclusive culture supporting diversity and curiosity.
• Opportunity to work on innovative projects and cutting‑edge technology.
• Comprehensive benefits: medical, dental, vision, short‑term and long‑term disability, company‑paid basic life insurance, 401(k) company match, generous paid time off and paid holidays, wellness and transportation benefits.

Compensation

The base pay range at commencement is $92,400 to $126,500, for an exempt role, with potential variation based on skills, experience and market value. Additional total rewards include discretionary annual bonus.

Equal Opportunity Statement

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.