Maintenance Mechanic

Job Description

Reporting to the Facilities Engineering Manager, the Maintenance Mechanic is responsible for providing expert general repairs, troubleshooting, PLC support and preventative maintenance activities on cGMP process equipment, utility systems, and facilities with minimal disruption to production. All work shall be in compliance with company SOPs and cGMP requirements.

The mechanic shall be expected to perform cGMP compliant documentation, execute Purchase Orders, help with establishing and maintaining a clean, orderly, and well-organized spare parts area.

Responsibilities

• Performs facility and manufacturing equipment evaluation, set up and repair. Includes: assessment, repair, preventive maintenance.
• Performs maintenance, repair and preventative maintenance ( P.M.) activities and completes related documentation as per the Standard Operating Procedure (SOP) for building, manufacturing, packaging and other equipment (e.g. compressed air, boilers, HVAC, Water for Injection and Clean Steam systems etc.)
• Works in compliance with established cGMP and safe work practices and procedures, using personal protection and safety equipment as required. Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace. Makes recommendations for remediation.
• Identifies, reports on, and repairs deficiencies in mechanical, electrical and PLC related equipment and systems throughout the plant. Identifies, sources, and orders appropriate/required equipment parts. Performs minor repairs including plumbing, painting, carpentry and other general repairs as needed in the facility.
• Fabricates (cuts, welds, assembles) components as may be required for repair or modification of equipment, including fitting piping in threaded, welded and sanitary configurations. May be required to liaise with outsource machine shops, fabricators and others providing services to address these needs.
• Must be able to operate safely all hand tools, power tools., multimeter tester and other equipment.
• Assists in supervision of contractor services as required and ensures that work is completed in accordance to Bimeda requirements, safety regulations and building code.
• Communicates daily Maintenance Activities with the Facilities Engineering Manager and team, as well as updates all daily logs.
• On-call for support required as per current Departmental “on-call" procedure. Weekend work and overtime will be required.
• Contributes to achieving department goals and continuous improvement. Assists in the development and implementation of new initiatives to improve quality and efficiencies in packaging and manufacturing.
• Maintains appropriate inventory of spare parts and works with the team to maintain an accurate parts database.
• Able to work in a Sterile environment on aseptic machines & must be sterile gown certified as per company policy
• Other duties as assigned

Job Requirements

Experience

• 5-10 years of maintenance experience in a cGMP manufacturing setting
  OR 5 years experience + completion of apprenticeship program or applicable Associates Degree in a technical field
• Ideal candidate should has 10+ years of maintenance experience in a pharmaceutical manufacturing setting.

Education

• High School Diploma or GED.
• Desirable to have a certain electrical certification.

Technical

• Knowledge of high speed filling / packaging lines and PLCs, aptitude in reading and interpreting diagrams, schematics, drawings, manuals, and specifications.
• Able to lift and move heavy or awkward objects, visual acuity, manual dexterity, some repetitive movements and work in confined spaces. Aseptic Qualification
• Ability to write coherently and clearly
• Basic knowledge of PLC systems
• Highly desired to have basic knowledge of Electrical systems; ability to program and troubleshoot PLC issues; knowledge of servo drives.

Behavioral

• High integrity, flexibility in working overtime, weekends, holidays, covering vacations / absences to support maintenance team.
• Analytical thinking, good problem solving skills
• Desirable to have coaching, training skills and patience with entry level Jr. Mechanics.

Language

• English
• Literacy in Spanish is a plus