Principal Process Engineer – Global MSAT
Overview
Just Evotec Biologics seeks a Principal Process Engineer to lead global MSAT initiatives focused on improving worldwide access to biotherapeutics. This role involves driving impactful projects and collaborating with talented individuals to achieve success.
What You'll Do12
- 1Project Lead for technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support
- 2Lead site to site Tech Transfer activities
- 3Ensure gap analysis/risk assessments are performed and mitigation plans are in place
- 4Develop templates for Process Validations and Continued Process Verification strategies
- 5Analyze process data including annual periodic reviews across manufacturing sites
- 6Create Process transfer document and Process Control strategy for Phase III and commercial programs
- 7Apply manufacturing process lifecycle management principles for establishing and continuous improvement of process control strategy
- 8Author regulatory CMC documents and coordinate responses to health authority questions
- 9Provide inspection support and guidance during regulatory and site inspections
- 10Manage direct reports and mentor junior process engineers
- 11Implement continuous process monitoring strategies and track process validation status
- 12Utilize statistical analysis and process risk assessment tools such as FMEA
Requirements11
- 1Bachelor’s degree in engineering science or related program with 12+ years relevant experience or 8+ years with an MS
- 2Subject matter expert in cell culture biopharmaceutical manufacturing including perfusion technologies and single use bioreactors
- 3Expertise in downstream processing such as chromatography, viral filtration, and tangential flow filtration
- 4Proven experience leading technology transfer and process validation for late-stage clinical manufacturing and commercial qualification PPQ campaigns
- 5Understanding of GMP concepts and quality systems for process transfer and validation
- 6Experience with continuous process monitoring and process validation throughout commercial lifecycle
- 7Background in statistical analysis and process risk assessment tools
- 8Knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems
- 9Strong focus on quality, attention to detail, and effective task/time management
- 10Strategic mindset to organize, analyze, interpret, and translate upstream expertise into global procedures
- 11Demonstrated skill in managing and mentoring direct reports
Salary Insight
$155 - $172k per year
Location
Required Skills
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