Position Details
About this role
This role involves supporting vaccine manufacturing operations, focusing on process transfer, validation, and compliance. The senior specialist will act as a technical expert in biologics production at the Wilson site.
Key Responsibilities
- Support vaccine process transfer and validation
- Lead troubleshooting and root cause analysis
- Prepare for regulatory inspections
- Manage deviation and change control
- Ensure quality attributes are met
Technical Overview
The position requires expertise in vaccine process transfer, validation, MES systems, and regulatory inspection readiness. It involves troubleshooting, process development, and ensuring GMP compliance in biologics manufacturing.
Ideal Candidate
The ideal candidate is a senior process engineer with extensive experience in vaccine manufacturing, process transfer, validation, and regulatory inspections. They should possess strong troubleshooting and root cause analysis skills, with a focus on quality and compliance in biologics or pharmaceutical production.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience in vaccine or biologics manufacturing, No experience with validation or regulatory inspections, Unwillingness to work in Wilson, NC
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