Senior Process Engineer
Evotec
full-time
Posted on:
Location Type: Office
Location: Redmond • Washington • United States
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Salary
💰 $112,560 - $154,100 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
- Support the development and implementation templates for Process Validations
- Support the analysis of process data including annual periodic reviews
- Develop Process transfer document and or Process Control strategy for phase III and commercial programs
Requirements
- Bachelor’s degree in engineering, science or related program
- 10+ years relevant experience or 8+ years of relevant experience with an MS
- Considered a subject matter expert in cell culture biopharmaceutical manufacturing
- Experienced in leading technology transfer and process validation activities
- Understanding of GMP concepts and quality systems necessary to execute process transfer
- Experience developing and providing oversight to continuous process monitoring strategies
- Experience authoring regulatory CMC documents
- Solid background in statistical analysis
- Significant experience with process risk assessment tools (e.g. FMEA)
- Working knowledge of manufacturing process equipment and automation systems (DeltaV)
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
- flexible work
- generous paid time off and 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
technology transferprocess validationstatistical analysisprocess risk assessmentregulatory CMC documentationcontinuous process monitoringprocess control strategygap analysisrisk assessment
Soft skills
leadershipcommunicationorganizational skills