The Mechanic’s prime responsibility is the installation, maintenance, repair and continuous improvement of all process machinery and systems in accordance with instruction manuals, blueprints, SOPs, cGMPs and safety procedures while focusing on eliminating breakdowns. They may also perform light facilities maintenance.
Key Responsibilities:
- Install and set up process equipment and other machinery as specified by Operations.
- Adjust (change over) functional parts of equipment and machinery to accommodate changes in products and packaging sizes and accurately document the activities in accordance with SOPs.
- Observe and test the operation of machinery and equipment to diagnose malfunctions by analyzing test results, machine error messages, or information obtained from operators.
- Disassemble machinery or equipment to remove parts and make repairs of malfunctioning equipment and identify parts needed for repairs using parts manual for specific equipment and prepare requisition for supervisor to order parts.
- Reassemble equipment after completion of inspections, testing, or repairs.
- Operate newly repaired machinery or equipment to verify the adequacy of repairs.
- Examine parts for defects, such as breakage or excessive wear.
- Proactively perform troubleshooting techniques in a logical manner on all equipment including pneumatic, hydraulic and utility systems.
- Responsible for the Preventive Maintenance (PM) of all process equipment.
- Maintain all maintenance workshop equipment.
- Source and prepare parts from stores for use in all repairs, W/O and PMs.
- Study blueprints or manufacturers' manuals to determine correct installation or operation of machinery
- Enter codes and instructions to program computer-controlled machinery.
- Maintain site programs including Lock Out, Confined Space, Hot Work permit etc.
- May prepare basic dimensional sketches.
- Maintain a clean and safe environment in compliance with State and Federal regulatory guidelines.
- In charge of site purified water system (maintenance, PM, calibrations etc.)
- Knows Optel system and willing to learn all aspects of Optel system
- Responsible for sitewide instruments/equipment calibrations
- Maintain stability chambers.
- Work on all work orders, document everything according to site GMP standards.
- Perform other duties and responsibilities as assigned.
Desired skills:
- Pharmaceutical OSD, liquid equipment experience including packaging experience with bottling & thermoformers.
- Cut and weld metal to repair broken metal parts, fabricate new parts, or assemble new equipment.
Qualifications:
- A technical degree or certificate is desirable or at least 5 years proven commercial pharmaceutical equipment maintenance experience.
- General: Comprehensive understanding of the cGMPs, OSHA and EPA regulations, IQ/OQ procedures, general accounting principles, personnel management, problem solving, decision making.
- Manufacturing: Comprehensive knowledge of manufacturing equipment and production unit operations.
- Packaging: Comprehensive knowledge of packaging equipment and operations.
- Administration: Excellent written and verbal presentation skills, documentation accuracy.
- Computer: Proficency in Word processing, e.g. Microsoft Word, spreadsheet databases e.g. Excel, electronic communication systems e.g. Microsoft Outlook, business management systems e.g. CMS.
