GMP Maintenance Technician - Weekends

Job description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! As a GMP Maintenance Technician you will play a vital role in ensuring the safe, efficient, and compliant operation of our production equipment in an aseptic environment. This position involves maintaining, troubleshooting, and repairing equipment and systems within a cGMP-regulated environment, while adhering to strict industry standards and regulatory requirements. The role requires technical expertise, attention to detail, and a strong understanding of GMP and FDA guidelines to ensure continuous operation and product quality. ### Responsibilities - Execute preventive and corrective maintenance activities on GMP equipment, including vial/syringe, bag filling stations, formulation, and packaging. - Identify and address any mechanical, electrical, or instrumentation issues that could affect production timelines or product quality. - Perform all maintenance work in compliance with GMP, SOPs, and regulatory guidelines. - Complete and maintain accurate documentation of all maintenance activities, including work orders, logs, calibration records, and equipment history. - Execute preventive maintenance activities to minimize downtime and ensure equipment reliability. Report any required corrective actions or replacements to management. - Conduct regular inspections of production equipment and facilities to identify potential issues, ensuring that all systems are operating efficiently and in compliance with regulatory standards. - Assist in commissioning and qualification activities for new equipment installations. - Maintain a consistent production floor presence in support of all production activities and participate in all production tier meetings between shifts. - Adhere to all company and regulatory safety standards, including those related to hazardous materials, electrical safety, lockout/tagout procedures, and PPE usage. - Collaborate with Engineering, Operations, and Quality teams to drive continuous improvement initiatives and to ensure equipment readiness and resolution of any issues that may impact production schedules or product quality. - Complete work orders assigned by the required SLAs. ### Qualifications - Education: High School diploma or equivalent required. Technical certification in industrial maintenance, HVAC, electrical, or a related field preferred. - 2+ years of experience in equipment maintenance or facilities management within a GMP-regulated environment, preferably in a pharmaceutical, biotechnology, or CDMO setting. - Experience with troubleshooting and maintaining manufacturing systems. - Familiarity with validation, qualification, and calibration processes in a GMP environment. - Strong understanding of GMP regulations, SOPs, and FDA guidelines. - Hands-on experience with mechanical, electrical, and instrumentation troubleshooting and repair. - Ability to read and interpret technical manuals, blueprints, and schematics. - Knowledge of safety standards and procedures in a regulated environment. - Good understanding of aseptic technique. - Strong problem-solving skills and attention to detail. - Ability to work independently and as part of a team in a fast-paced environment. ### Physical Requirements - Ability to lift and move up to 40 lbs. - Ability to work in various environments, including confined spaces and heights. - Ability to stand, walk, kneel, or bend for extended periods of time. - Previous experience in a Contract Development and Manufacturing Organization (CDMO) or similar environment.