The GMP Asset Mechanic is responsible to ensure that GMP production assets are evaluated prior to purchase, qualified and documented as needed, maintained and commissioned prior to use, and properly decommissioned and stored for future use. These individual reviews: equipment and room design, executes qualification and maintenance activities, troubleshoots and assesses failures and corrective work as well as implement applicable preventative actions, and provides input for the development of maintenance plans, tasks, procedures, and schedules. The individual recommends and/or procures spare parts and consumables. Individual will provide supervision of external contractors to maintain equipment while documenting historically significant activities as directed.
Key Accountabilities
Performs planned and unplanned maintenance on assets in a GMP environment and ensures activities are properly documented.
Troubleshoot equipment and system failures and determines or supports determination of root cause and recommends/performs corrective actions and preventative measures.
Manages and issues equipment tooling, ensuring that tools are maintained properly, tracked, kitted for use, and available.
Coordinates and performs equipment relocation ensuring no damage is incurred during the move and that asset is fully functional and within specification before releasing asset for use.
Supports installation of new equipment which may include FAT, SAT, execution of qualification protocols, and determination of maintenance plans and spare parts
Work cross-functionally with other resources (operations, purchasing, planning, QA, Project Management, laboratory, manufacturing, etc.) to schedule, perform and properly document any and all relevant tasks pertaining to GMP Assets.
Utilizes and develops task lists and maintenance plans derived from experience, asset manuals, and review with manufacturer technical support regarding equipment commissioning, setup, operation, maintenance, and decommissioning.
Develops and performs; work orders, work permits, change controls, and writes, reviews and/or approves Standard Operating Procedures (SOPs), specifications, and other procedures as required.
Training of personnel regarding equipment maintenance, setup, operation, cleaning, SOPs, etc.
Follow Lonza safety guidelines and participate in safety processes and meetings as applicable.
Provide input for forecasting of budget requirements and help to manage department expenses
Maintain a positive, professional, and confidential relationship with internal customers, clients, and vendors.
Comply with all state and federal regulatory requirements and guidelines.
Provide 24-hour emergency support as defined and perform other applicable duties as assigned.
Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
Stop work where deemed necessary to maintain safety
Education & Experience
High school diploma or equivalent required.
Technical certification, associate's degree, or vocational training in mechanical, electrical, mechatronics, or related field preferred.
Minimum 5 years' experience in GMP maintenance, equipment mechanics, or similar technical role in a regulated industry (pharma, biotech, or manufacturing).
Additional training in safety, compliance, or maintenance systems (CMMS/Maximo/SAP) is a plus.
Numbers & Facts
Location
Tampa, FL
Skills
Biotech and Pharmaceuticalunmatched
Budget Forecastingunmatched
Change Controlunmatched
Commissioningunmatched
Computerized Maintenance Management System (CMMS)unmatched
Corrective Actionunmatched
Cross-Functionalunmatched
Customer Relationsunmatched
Documentationunmatched
Electricityunmatched
Equipment Maintenance/Repairunmatched
Expense Managementunmatched
Failure Analysisunmatched
Federal Laws and Regulationsunmatched
GMP (Good Manufacturing Practices)unmatched
IBM Maximo Asset Managementunmatched
Identify Issuesunmatched
Laboratory Managementunmatched
Machine Toolunmatched
Maintenance Servicesunmatched
Manufacturingunmatched
Manufacturing Technologyunmatched
Mechanical Maintenanceunmatched
Procurement Planningunmatched
Project/Program Managementunmatched
Purchasing/Procurementunmatched
Quality Assuranceunmatched
Regulatory Requirementsunmatched
Root Cause Analysisunmatched
SAPunmatched
Safety Complianceunmatched
Safety Processunmatched
Safety Trainingunmatched
Staff Trainingunmatched
Standard Operating Procedures (SOP)unmatched
State Laws and Regulationsunmatched
Sustainabilityunmatched
Technical Supportunmatched
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