Maintenance Manager / Engineering Manager Position Summary The Maintenance Mechanic is responsible for maintaining, troubleshooting, repairing, and improving manufacturing equipment used in the production and packaging of OTC pharmaceutical products, including suppositories, creams, ointments, gels, and lotions. The role ensures equipment reliability while maintaining compliance with cGMP, FDA, OSHA, and company quality standards. Key Responsibilities Perform preventive, predictive, and corrective maintenance on manufacturing and packaging equipment. Troubleshoot mechanical, pneumatic, hydraulic, and basic electrical issues to minimize downtime.
Maintain and repair:
Cream and ointment mixing kettles Homogenizers Vacuum emulsifiers Suppository melting, filling, and cooling equipment Tube fillers and crimpers Jar and bottle filling equipment Cartoners, labelers, and case packers Conveyors and pumps Assist with equipment installation, qualification, and commissioning. Perform equipment changeovers and line setup. Read mechanical drawings, equipment manuals, and SOPs. Complete maintenance work orders accurately using the CMMS. Maintain spare parts inventory and recommend critical spare requirements. Support validation activities and equipment
IQ/OQ/PQ
as required. Ensure all maintenance activities comply with cGMP documentation requirements. Participate in root cause investigations and implement corrective and preventive actions (CAPA). Work closely with Production, Quality Assurance, and Validation teams. Maintain clean and organized maintenance work areas following GMP standards. Support continuous improvement and reliability initiatives. Qualifications High school diploma or GED required. Technical certification or associate degree in Industrial Maintenance, Mechanical Technology, or related field preferred. 3-7 years of industrial maintenance experience, preferably in pharmaceutical, cosmetic, food, or medical device manufacturing. Experience with sanitary process equipment is highly desirable. Technical Skills Mechanical troubleshooting Pneumatic systems Hydraulic systems Bearings, seals, pumps, and gearboxes Conveyor systems Basic electrical troubleshooting (480V, motors, sensors, VFDs preferred) Welding and fabrication (preferred) Familiarity with PLC-controlled equipment (troubleshooting only) Ability to use precision measuring tools and hand tools Regulatory Knowledge OSHA safety requirements Lockout/Tagout (LOTO) Hazard Communication Physical Requirements Lift up to 50 pounds. Stand, walk, bend, climb ladders, and work in confined spaces as needed. Work occasional overtime, weekends, or on-call shifts during production demands. Key Competencies Strong troubleshooting and problem-solving skills Attention to detail Teamwork and communication Ability to work independently Sense of urgency with safety and quality focus Strong documentation skills Commitment to equipment reliability and continuous improvement Preferred Experience OTC pharmaceutical manufacturing Suppository manufacturing equipment Cream and ointment processing Tube filling and cartoning equipment CMMS systems (e.g., eMaint, SAP PM, Maximo) TPM and Lean Manufacturing principles This description is suitable for an FDA-regulated OTC manufacturing facility producing topical creams, ointments, gels, lotions, and suppositories, and aligns with typical GMP expectations for pharmaceutical maintenance personnel.
Pay:
From $34.00 per hour
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance
