E
Not Specified Permanent

Bellevue, Washington · USA job

Process Engineer III - Site Based, Redmond, WA

Evotec Group

Bellevue, Washington

Job description

Overview

As Process Engineer III in the Global MSAT Tech Transfer team, you will support downstream tech transfer for late-stage and commercial biologics across Just Evotec's manufacturing network. You'll help build global transfer templates, assess risks, and generate documentation for PPQ and regulatory needs. You'll work cross-functionally to ensure scalable, compliant processes and contribute to innovative manufacturing solutions. This role offers broad exposure to global projects and real impact on patient access to therapies.

Compensation / Benefits
  • discretionary annual bonus
  • comprehensive benefits suite (medical, dental, vision)
  • 401k with company match
  • paid time off and holidays
  • wellness and transportation benefits
  • flexible work environment
Responsibilities
  • Support downstream tech transfer for late-stage and commercial manufacturing campaigns
  • Coordinate site-to-site transfer activities and build design spaces for critical parameters
  • Develop and review technical docs for performance qualifications, batch records, and GMP/PPQ runs
  • Author templates for Process Validations and Continued Process Verification
  • Analyze process data and conduct periodic reviews across manufacturing sites
  • Prepare process transfer documents and process control strategies for phase III and commercial programs
Key requirements
  • Bachelor's degree in engineering, sciences, or related field; 5+ years of relevant experience, or 2 years with MS degree
  • Experience with process transfer/tech transfer in the biopharmaceutical industry; experience with commercial campaigns
  • Familiarity with risk assessment tools (e.g., FMEA) and process modeling/trending
  • Strong understanding of downstream processing (chromatography, continuous chromatography, large-scale packing, viral filtration, TFF)
  • GMP/compliance knowledge to support tech transfer and validation activities
  • Hands-on downstream disposable manufacturing technologies from bench to manufacturing scale
  • Knowledge of manufacturing process equipment and automation systems
  • Ability to analyze and communicate process data; strong collaboration and communication skills
  • Ability to navigate global regulatory CMC documents
  • Experience with late-stage manufacturing, tech transfer, or process validation; DeltaV experience (preferred)
  • collaborative
  • attention to detail
  • strong written and oral communication
  • downstream processing
  • continuous chromatography
  • large-scale column packing

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