Principal Process Engineer
Evotec
full-time
Posted on:
Location Type: Office
Location: Redmond • Washington • United States
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Salary
💰 $155,000 - $172,000 per year
Job Level
About the role
- Project Lead for technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support
- Lead site to site Tech Transfer activities
- Ensure gap analysis/risks assessments are performed and mitigation plans are in place
- Support development, review and approval of technical documentation
- Lead the development and implementation templates for Process Validations
- Analyze process data including annual periodic reviews across the network
- Develop Process transfer document and or Process Control strategy
Requirements
- Bachelor’s degree in engineering science or related program
- 12+ years relevant experience or 8+ years of relevant experience with an MS
- Subject matter expert in downstream processing, including downstream process chromatography
- Knowledgeable in single-use bioreactors and perfusion technology
- Experienced in leading technology transfer and process validation activities
- Understanding of GMP concepts and quality systems
- Experience developing and providing oversight to continuous process monitoring strategies
- Solid background in statistical analysis
- Significant experience with process risk assessment tools (e.g. FMEA)
- Demonstrated skill managing and mentoring direct reports
Benefits
- 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
- generous paid time off
- paid holiday
- wellness and transportation benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
technology transferprocess validationdownstream processingchromatographysingle-use bioreactorsperfusion technologystatistical analysisprocess risk assessmentFMEAcontinuous process monitoring
Soft Skills
leadershipmentoringcommunicationgap analysisrisk assessmentproblem-solvingorganizational skillscollaborationoversightdocumentation review