LOCATION: Madison area
Under direction of the Process Engineering Manager, the Maintenance Team Lead 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:
- Coordinate maintenance and repair work of the facility; prepare schedules and work assignments, direct and perform work
- Coordinate maintenance between shifts
- Develop and maintain a preventative maintenance schedule program for applicable equipment and machinery; to include manufacturer recommendations and installation notes of new equipment from the General Contractor during start-up.
- Repair and maintain machinery and mechanical equipment such as pumps, motors, tanks, mixers, and Allen Bradley electronics.
- Support the training of other maintenance department employees.
- Arrange for and manage appropriate third-party contactor support; as needed.
- Prepare and secure estimates and cost quotes; as needed.
- 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 area or advise manager of repair needs.
- Collect and discard worn machine parts and other refuse to maintain machinery and work areas.
- Record production, repairs, and machine maintenance information and maintain cGMP records (paper and electronic).
- Inventory and requisition machine parts, equipment, and other supplies so that stock can be maintained and replenished.
- Respond to alarms and document activities.
- Maintain operation of cGMP utility equipment, including: Chillers, HVAC, Dust Collection, Boilers/Steam, Freezers, Compressors, Lighting, Electrical, Water/Plumbing systems.
- Maintain a clean, sanitary and safe work area.
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.
- 5+ years of relevant experience in an FDA-regulated or controlled manufacturing environment, preferably dietary supplements 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, dietary supplement regulations, food regulations, and product safety.
- Excellent communication, organizational, planning, problem-solving and follow-up skills.
- Ability to work effectively as a team player in a diverse work group.
- Ability to comply with company policies and procedures and maintain regular work attendance.
- Ability to read and interpret control wiring and logic diagrams for PLC & Automation equipment, P&IDs and general arrangement for process equipment and utilities
- Knowledge of root cause analysis and other problem-solving methods.
- 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.
- Other duties as required.
To apply, please send your resume to firstname.lastname@example.org