Michael Martinez
- Role
- Associate Director, Automation Maintenance at Hikma Pharmaceuticals
- Location
- Columbus, OH, US
- LinkedIn followers
- 500 followers
About Michael Martinez
Experienced manager with a demonstrated history of working in the pharmaceuticals…
Experience
Associate Director, Automation Maintenance
Jun 2012 — Present
Manage a 24/7 staff of sixteen ISA Certified Control System Technicians responsible for calibrations, automation maintenance, preventive maintenance and troubleshooting of manufacturing, packaging, environmental and facilities equipment. • Provide expert technical leadership in calibration practices and troubleshooting system issues to technicians. • Communicate equipment breakdown, repair status and abnormal events to site and departmental leadership. • Manage all aspects of the sites cGMP calibration program including regulatory authority audit support, development of standard operating procedures and work instructions, calibration data review and work order closure, calibration frequency, criticality and test point optimization, metric development and tracking. • Develop and execute qualification and testing strategies for equipment control and related systems in collaboration with Validation, Quality, Operations, Engineering and Capital Projects groups. • Lead calibration failure risk assessment process including root cause analysis, corrective and preventive action (CAPA). • Resource planning and allocation for daily work, project support and plant shutdowns including cost center budget development and adherence. • Create, track and execute change controls using TrackWise for new equipment, new equipment calibration tasks and updates to existing calibration maintenance plans. • Lead automation maintenance related segments of Capital Projects. • Manage on-site contracted calibration service providers including contract development, oversight and site specific training.
Skills
- Cgmp
- Root Cause Analysis
- Validation
- Preventive Maintenance
- Metrology
- Process Automation
- Capa
- Gmp
- Calibration
- Cross-Functional Team Leadership
- Quality Assurance
- Six Sigma
- Sop
- U.s. Food and Drug Administration (Fda)
- Change Control
- Quality System
- Pharmaceutical Industry
- Reliability Centered Maintenance
- 21 Cfr Part 11
- Fda
- Process Improvement
- Continuous Improvement
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