Specialist, Bioprocess Engineer
msd · De Millsboro
Job description
About the role
The Specialist, Bioprocess Engineer will join the BioTechnology Solutions (BTS) Americas Strategic Projects team within Animal Health. The role focuses on supporting vaccine technology transfers, technical risk assessments, and post‑transfer process robustness across regional sites.
Key responsibilities
- Prepare technical inputs and documentation for vaccine technology transfers and coordinate readiness activities.
- Conduct technical risk assessments, gather data for fit‑gap evaluations, and implement mitigation action plans.
- Maintain transfer packages, playbooks, lessons learned, and best‑practice documentation for regional knowledge management.
- Monitor post‑transfer process performance, support troubleshooting, and drive continuous improvement with Quality and site teams.
- Draft and review protocols, reports, summaries, and trackers to ensure compliance with quality and regulatory expectations.
Required profile
- Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmacy, or related field.
- Minimum 2 years experience in biopharmaceutical, antigen, or vaccine manufacturing, bioprocess engineering, process development, or technology transfer.
- Experience working in a regulated GxP environment with strong documentation and data‑integrity focus.
- Ability to support technical problem solving, investigations, and basic risk‑management tools such as FMEA.
- Strong collaboration skills and ability to manage multiple priorities in a matrixed environment.
Required skills
- Upstream bioprocessing
- Downstream bioprocessing
- Fill‑finish operations
- Lyophilization processes
- GxP regulated environment
- Technical documentation
- Data integrity
- Risk assessment (FMEA)
- Process characterization
- Scale‑up and scale‑down concepts
- USDA regulatory compliance
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Published 1 day ago
Expires 1 month from now
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msd
De Millsboro
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