Filling Specialist
Core
Operates and maintains aseptic filling lines for sterile injectable cartridges and combination products, ensuring GMP compliance and product quality.
Role type
Manufacturing Filling Specialist (Production IC)
Builds
Sterile injectable cartridges and combination products
Domain
Pharmaceutical manufacturing / CDMO
Required skills
Aseptic techniques, GMP compliance, machine setup and disassembly, line changeovers, sanitization, in-process quality checks, troubleshooting, preventative maintenance, gowning certification, mechanical aptitude, documentation practices
Preferred skills
Training new operators, MDI and DIR investigations, Overall Equipment Efficiency participation
Technologies
Filling machines, aseptic filling equipment
Responsibilities
Perform line changeovers, sanitization, and cleaning; set up and disassemble filling machines; model aseptic practices; perform in-process quality checks; troubleshoot and adjust filling machines; provide preventative maintenance support; oversee operators; train new filling room operators; update SOPs; assist with investigations.
Seniority
Mid-level, hands-on IC
