Lead, implement, and manage all Automation and calibration functions for a Sterile Drug Products GMP Filling facility
Job Summary
Lead, implement, and manage all Automation and calibration functions for a Sterile Drug Products GMP Filling facility.
Develop effective maintenance strategies, implement preventive maintenance programs, and ensure regulatory compliance while minimizing equipment downtime.
Work with cross-functional teams, support maintenance staff development, and implement continuous improvement initiatives to optimize equipment performance and reliability.
Matching Summary
Lead, implement, and manage all Automation and calibration functions for a Sterile Drug Products GMP Filling facility.
Skills & Requirements
Must-have
Automation and calibration function management
Preventive maintenance programs
Regulatory compliance
Cross-functional team collaboration
Continuous improvement initiatives
GMP procedures compliance
Subject Matter Expert (SME) for audits
Nice-to-have
Sterile Drug Product Fill Finish equipment
Clean Room BMS/EMS automation
Clean Utility automation experience
Key Requirements
Bachelor's Degree in Engineering
8-10 years relevant experience in Bio-pharmaceutical industry
Experience managing a team
Expert knowledge of cGMP and regulatory standards (FDA, EMA)
Strong understanding of electrical, Instrumentation, hydraulic, and pneumatic systems
Experience with maintenance programs and strategies
Experience managing equipment qualification and validation