Maintenance Mechanic/ GMP Asset Mechanic Position Available In Hillsborough, Florida

Maintenance Mechanic/ GMP Asset Mechanic

Job Title:

Maintenance Mechanic/ GMP Asset Mechanic

Location:

4910 Savarese Circle, Tampa, FL 33634

Duration:

12 Months (Possible Extension or Conversion)

Position Type:

Hourly contract Position (W2 only)
Description
:
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.

This individual reviews:

equipment and room designs, 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
5 years’ experience

Additional Details:

The GMP Asset Mechanic role is divided into three levels, based on increasing accountability and technical proficiency. All levels support safe and reliable operation of oral dosage manufacturing equipment.
Essential Job Functions
Participate in equipment changeover and setup as required
Maintain inventory of necessary spare parts to minimize equipment downtime
Research, request, and procure components and equipment as needed
Perform maintenance activities safely, efficiently, and in compliance with GMP standards
Complete all required documentation (work orders, logbooks, cGMP forms) accurately and on time
Assist in equipment installation and retrofit projects, including qualification activities
Support equipment troubleshooting with engineers, operators, and vendors
Collaborate with cross-functional teams (QA, EHS, Operations, Engineering) to resolve technical issues
Participate in continuous improvement efforts related to equipment uptime and reliability
Ensure compliance governmental regulations, policies, and procedures
Track and support maintenance metrics (e.g., PM completion rate, downtime)
Provide hands-on support to manufacturing and technical teams as needed
Assume temporary leadership responsibilities in the absence of Maintenance Team Leader
Participate in internal/external training to support personal development and advancement

Additional Expectations:

Flexibility to support shift coverage, weekend work, or emergency response when needed
Tiered Technical Accountabilities
A check mark () indicates that the technician is expected to perform that responsibility independently and consistently at the specified level.
Accountability
Tech I
Tech II
Tech III
1. Execute routine maintenance under supervision
2. Execute minor repairs under supervision
3. Perform most routine maintenance independently
4. Diagnose and perform most repairs independently
5. Identify proper equipment setup
6. Perform all routine maintenance
7. Diagnose and perform all repairs independently
8. Provide process optimization feedback
9. Identify root causes and implement improvements
10. Temporarily assume leadership during absence
Tiered Functional Competencies
A check mark () indicates that the technician is expected to have demonstrated competency or working knowledge in that area at the specified level.
Competency
Tech I
Tech II
Tech III
Plumbing (Repair/Fabrication)
Heat Exchangers
Valves (Control, Manual, Regulator)
Control Loops (Temp, Pressure, etc.)
Automation (PLC, HMI, Panel View)
Vision Systems
Electrical/Electronics
Pneumatics
Mechanical
Hydraulics
Technical Drawings/Literature
Technical Writing
Granulation Equipment
Encapsulation Equipment
Compression Equipment
Blending, Mixing, Milling, Sieving
Tablet Coating Equipment
Solution Prep Equipment (Tanks, Mixers)
Packaging Equipment (Powders)
Packaging Equipment (Tabs/Caps)
Serialization Equipment
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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Dice Id:

sunrise

Position Id:

25-08169