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.
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.
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