Production Engineer (2-2-3 schedule Nights)
Core
Provide 24/7 technical support and expertise to sterile pharmaceutical production, ensuring compliance with regulatory and cGMP standards while minimizing equipment downtime.
Role type
Production Engineer (Sterile Pharmaceutical Manufacturing)
Builds
Sterile fill/finish operations and pharmaceutical production lines
Domain
Pharmaceutical manufacturing / Biotech / Medical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Troubleshooting, Analytical skills, Process improvement (Lean, Six Sigma, 5S), Data integrity principles, Automation systems knowledge, Equipment operation, Process flow diagram creation, SOP compliance
Preferred skills
Regulated manufacturing experience, Data-driven metrics analysis, TPM implementation
Technologies
Automation systems, Data integrity platforms
Responsibilities
Diagnose and resolve complex process and equipment issues, Serve as Subject Matter Expert (SME) on equipment and process functionality, Develop process flow diagrams, troubleshooting guides, and training materials, Support CAPEX equipment upgrades for sterile fill/finish operations, Coordinate planned shutdowns and production interruptions, Create, modify, and approve process equipment recipes in compliance with SOPs, Spend 70–90% of time on the production floor supporting operations
Seniority
Mid-level, hands-on IC
