Maintenance Technician - Sterilization & Lyophilization
6 days ago
North Charleston
Position Summary RTD Biosciences is seeking a dependable and mechanically inclined Maintenance Technician to support the operation, maintenance, and reliability of facility infrastructure, utilities, manufacturing equipment, and building systems within a cGMP-regulated pharmaceutical manufacturing environment. This position plays a critical role in ensuring equipment uptime, maintaining facility systems, supporting production operations, and performing preventive and corrective maintenance while complying with FDA regulations, current Good Manufacturing Practices (cGMP), OSHA requirements, and company policies. The Maintenance Technician works closely with Facilities, Engineering, Manufacturing, Quality, and Validation teams to ensure safe, reliable, and efficient operation of the facility. Key Responsibilities • Perform preventive, predictive, and corrective maintenance on manufacturing equipment, facility infrastructure, and utility systems., • Troubleshoot mechanical, electrical, pneumatic, hydraulic, and control system issues to minimize equipment downtime., • Inspect, repair, and maintain production equipment, HVAC systems, compressed air systems, purified water systems, vacuum systems, boilers, chillers, and other facility utilities., • Support installation, relocation, startup, and commissioning of new equipment and facility systems., • Perform routine inspections of facility equipment and identify potential maintenance or safety concerns., • Complete work orders accurately using the company's maintenance management system (CMMS)., • Maintain detailed maintenance logs, calibration records, and equipment documentation in compliance with cGMP requirements., • Assist with equipment qualifications (IQ/OQ/PQ), preventive maintenance programs, and validation activities., • Coordinate with outside contractors and vendors performing maintenance or repair work., • Support emergency repairs to minimize disruption to manufacturing operations., • Assist with facility modifications, construction projects, and equipment improvements., • Maintain spare parts inventory and notify management of replacement part requirements., • Participate in root cause investigations and continuous improvement initiatives., • Ensure all work is performed safely and in compliance with OSHA, FDA, EPA, and company policies., • Maintain a clean, organized, and inspection-ready maintenance shop and work areas. Qualifications & Requirements • High School Diploma or GED required., • Technical school certification, vocational training, or Associate degree in Industrial Maintenance, Mechanical Technology, Electrical Technology, HVAC, Mechatronics, or related field preferred., • 2–5 years of industrial maintenance experience in pharmaceutical, biotechnology, food manufacturing, medical device, or other regulated manufacturing environment preferred., • Experience troubleshooting mechanical and electrical equipment., • Working knowledge of cGMP and FDA-regulated manufacturing environments preferred., • Ability to read equipment manuals, mechanical drawings, electrical schematics, and piping diagrams., • Strong troubleshooting, problem-solving, and organizational skills., • Proficiency with hand tools, power tools, and maintenance equipment., • Basic computer skills with Microsoft Office and CMMS software., • Ability to lift up to 50 pounds and work in physically demanding environments. Preferred Experience • Pharmaceutical or biotechnology manufacturing facilities., • HVAC maintenance and troubleshooting., • Clean utilities (compressed air, purified water, vacuum systems)., • Electrical systems (120V–480V)., • Pneumatic and hydraulic systems., • Pumps, motors, conveyors, and process equipment., • PLC troubleshooting (not programming required)., • Calibration support., • Preventive Maintenance (PM) programs., • CMMS systems., • Facility and building maintenance., • Equipment installation and commissioning. Work Environment • Pharmaceutical manufacturing and laboratory environment., • Combination of office, mechanical rooms, production areas, warehouse, and cleanroom spaces., • Frequent standing, walking, climbing ladders, kneeling, bending, and lifting., • Exposure to moving mechanical equipment and industrial utility systems., • May require occasional evening, weekend, holiday, or emergency call-in support. Safety & Compliance Practices • Follow all company safety policies and procedures., • Perform work in accordance with OSHA regulations and cGMP requirements., • Comply with Lockout/Tagout (LOTO), confined space, hot work, fall protection, and electrical safety procedures., • Wear required Personal Protective Equipment (PPE)., • Report unsafe conditions, equipment failures, and maintenance concerns immediately., • Support a culture of safety, quality, reliability, and continuous improvement. Physical & Environmental Requirements • Ability to lift and carry up to 50 pounds., • Ability to stand and walk for extended periods., • Ability to climb ladders and work from lifts., • Ability to work in mechanical spaces, rooftops, utility rooms, and cleanroom environments., • Ability to work in varying temperatures and around operating industrial equipment., • Manual dexterity to use maintenance tools and diagnostic equipment. Key Competencies • Mechanical aptitude, • Electrical troubleshooting, • Preventive maintenance, • Equipment reliability, • Attention to detail, • Safety awareness, • Problem solving, • Team collaboration, • Time management, • Customer service mindset, • Adaptability in a fast-paced manufacturing environment Reporting Relationship Reports to: Facilities Manager