Maintenance Technician – 1st shift
Under direction of the Engineering and Maintenance Manager, theMaintenance Technician will be responsible for all repairs and preventative maintenance activities on cGMP process equipment, utility systems and facilities.
To perform this job successfully, an individual must be able to perform each essential job duty. Essential job functions and duties include, but are not limited to:
- Repair and maintain machinery and mechanical equipment typical of a probiotic manufacturing facility.
- Support the training of maintenance and operations employees.
- Dismantle machines and remove parts for repair using hand tools, jacks, cranes, hoists or dollies and reassemble machines after completion of repair or maintenance work in compliance with Quality System procedures as well as production specification.
- Inspect or test damaged machine parts, and mark defective areas or advise supervisor of repair needs.
- Collect and discard worn machine parts and maintain machinery and work areas in compliance to safety and sanitary requirements.
- Complete required documentation (paper and electronic) for preventative and corrective maintenance, equipment start-up, decommissioning etc., in accordance with a cGMP quality system.
- Inventory and requisition machine parts, equipment, and other supplies so that stock can be maintained and replenished.
- Maintain operation of cGMP utility equipment, including: HVAC, Dust Collection, Coolers, Compressors, Lighting, Electrical, Water/Plumbing systems.
- Respond to unscheduled equipment downtime events and document activities.
- Collaborate with co-workers to determine root cause of failures while making recommendations (and implementing corrective actions) to avoid or mitigate future events.
- Provide set-up and start-up support for operators as needed.
- Assists in the improvement to enhance equipment or system efficiency, reduce energy cost/usage and other cost saving/avoidance projects.
- Strictly adhere to Current Good Manufacturing Practices (cGMP), and Standard Operating Procedures(SOPs) and report all discrepancies
- Write or modify PM procedures.
The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:
- Associates degree or equivalent combination of education and work experience.
- 2+ years of relevant experience in an FDA-regulated or controlled manufacturing environment, preferably food ingredient, live cultures, or pharmaceuticals.
- Provide “on-call” support on a rotating basis.
- Must be willing to work overtime, weekends, holidays, and varying shifts, as required.
- Knowledgeable in GMP, inspection guidelines, sanitation, food regulations, and product safety.
- Excellent communication, organizational, planning, problem-solving and follow-up skills.
- Ability to comply with company policies and procedures and maintain regular work attendance.
- Ensures optimum operation of all production equipment and machinery by trouble shooting, diagnosing and repairing any problems in a timely manner and performing scheduled Predictive Maintenance.
- Demonstrates excellence in all typical maintenance functions and functional understanding of: motors, valves, heat exchangers, instrumentation, pumps, agitators, alignments, seal replacement, chillers, boilers, variety of tools, gear pullers, hydraulic press, drilling and tapping new threads, and office space related maintenance.
- Ability to work effectively as a team player and continuous learner. Positive attitude and willingness to teach operators and others about process equipment
- Other duties as required.
- 5+ years of relevant experience in an FDA-regulated or controlled manufacturing environment, preferably food ingredient, live cultures, or pharmaceuticals.
- Knowledge of root cause analysis and other problem-solving methods.
- Ability to read and interpret control wiring and logic diagrams for PLC & Automation equipment, P&IDs and general arrangement drawings for manufacturing equipment and utilities.
- Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
- Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
Skills in related tasks: welding, pipe fitting, machinist, fabrication, oil and vibration analysis, etc.
- Experience in a cGMP environment.