Associate Specialist, Engineering (Onsite)
Core
Support sterile clinical manufacturing facility design, commissioning, qualification, and operations for drug product development.
Role type
Associate Specialist, Technical Operations and Operations
Builds
Sterile clinical manufacturing capacity for small molecule, biologics, and vaccine drug products
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
GMP compliance, aseptic handling, facility design, manufacturing systems, engineering principles, technical documentation, problem-solving
Preferred skills
GMP operations, manufacturing process engineering, mechanical engineering, change control, deviation management
Technologies
SAP, HMIs, calibration databases, Microsoft Office
Responsibilities
Support equipment and facility design, system commissioning/qualification, regulatory certification, aseptic formulation/filling/lyophilization operations, batch documentation, deviation investigations, and process improvements
Seniority
Entry-level, hands-on IC