Senior Specialist, Engineering- Biologics External Manufacturing Technical Operations
Listed on 2026-10-09
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Pharmaceutical
Pharmaceutical Manufacturing, Validation Engineer, Regulatory Compliance Specialist, Quality Engineering -
Manufacturing / Production
Pharmaceutical Manufacturing, Validation Engineer, Regulatory Compliance Specialist, Quality Engineering
Senior Specialist in Engineering for Biologics External Manufacturing Technical Operations, focusing on drug substance tech transfer and commercial production within the external manufacturing network.
Responsibilities:lead technical transfer activities, serve as primary interface with external partner drug substance manufacturers, author/review GMP documentation, manage process improvements, and support regulatory inspections. Ensure external partners meet GMP compliance and inspection readiness, develop standardized work, and drive continuous technical excellence.
Requirements:Bachelor's in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, or related field; 8+ years post-bachelor's GMP experience in operations, engineering, or technical support; strong problem-solving, communication, and organizational skills; ability to work independently and multi-task under tight deadlines.
Preferred:experience in biologics or large molecule manufacturing, project management, deviation/change management, and knowledge of global regulatory requirements.
High Value:biologics/vaccines manufacturing, drug substance tech transfer, GMP compliance, sterile processes, regulatory support, 25% travel.
Work Setup:in-office with travel.
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