Summary Description: The Master Mechanic will be responsible for the identification of machine problems and troubleshoot the repairs; for performing machine adjustments to GMP equipment, including preventive maintenance, setting-ups, fine-tunes; and for supporting the installation, testing and documentation/logs of a wide variety of manufacturing and packaging equipment such as filling, mixing tanks, pumps, heaters, etc. which are used in the production of both over the counter (OTC) and prescriptions (Rx) products.
Master Mechanics are responsible for, but not limited to:
- Perform Preventive Maintenance per applicable Standard Operating Procedures (SOPs) to keep equipment in good working condition and ensure work order documentation is completed accurately and entirely.
- Document job completion in equipment logbooks and work orders paperwork in accordance with current good manufacturing practices (cGMP).
- Perform corrective maintenance repairs in accordance with equipment manuals in timely fashion for all corrective maintenance and emergency needs.
- Synchronize the weekly mechanic set up activities with the Set-up/Cleaner Coordinator and/or Maintenance Manager.
- Leverage knowledge of GMP, mechanical system, basic welding, to provide training/guidance for the development of the set-up mechanics capabilities in diagnosis and troubleshooting of equipment’s issues. (two or more set-ups employees).
- Assist in the creation/improvement of Standard Operating Procedures (SOP’s), Work Order Maintenance Plans, Hazard Risk Assessments (HRA), Factory Acceptance Tests (FAT) and Equipment Setup Instructions (ESI).
- Support new equipment installations, line modifications, validation activities, process improvements, etc.
- Evaluate potential equipment issues/failures and communicate possible solutions to maintenance management team.
- Support production by assisting with the following activities: setting up filling and packaging lines according to PNY’s ESI/SOPs, setting Lot/Batch numbers and expiration date on customer order, etc.
- Perform other activities as deemed by Maintenance Manager or Plant Manager.
- Troubleshoot and diagnose the Human Machine Interface (HMI) to resolve equipment issues.
- Fillers: Tube, Liquid & Suppository.
- Machines: Wrapper, Cartoner, Unscramble Bottlers, Capper, Conveyors
- Case: Sealers & Packers
- Pumps, mixers, and storage tanks.
- Ability to wear any type protective equipment as directed by job requirements.
- Ability to prioritize conflicting demands, to complete tasks with minimal supervision and to work with all levels of the organization to meet common goals.
- Provide support as needed - this may be outside of normal working hours including nights, weekends and holidays.
- Must have English language fluency, both written and verbal, with the ability to communicate at all levels within the organization.
- Must have computer skills (Microsoft office).
Five (5) years working as a mechanic or lead mechanic in the preferred industry with a letter of recommendation from previous job preferred in the set-up area. Preferably in Pharmaceutical, Food or Packaging industry.
Two (2) years of college in industrial or mechanical curriculum preferred, but not require if the candidate meets the 5 years or more of experience by providing a letter of recommendation.
Other: High school diploma, GED and or 1 year of college. Trade school graduate or completion of a recognized apprenticeship program with three (3) years’ experience as a mechanic.
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