GMP Maintenance Technician: Aseptic Equipment Expert

August Bioservices

Nashville (TN)

On-site

USD 52,000 - 76,000

Full time

14 days+

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Job summary

August Bioservices, based in Nashville, seeks a GMP Maintenance Technician to keep production equipment running in a cGMP environment. You will troubleshoot, repair, calibrate, and document maintenance, working with Engineering, Operations and Quality to meet production schedules.

Ideal candidates have a high school diploma or equivalent, 2+ years of GMP maintenance experience, and familiarity with validation and calibration processes, reading manuals and schematics, and a commitment to safety

Qualifications

High School diploma or equivalent required.
Technical certification in industrial maintenance, HVAC, or electrical preferred.
2+ years in equipment maintenance or facilities management in a GMP-regulated environment.
Experience troubleshooting and maintaining manufacturing systems.
Familiarity with validation, qualification, and calibration processes in GMP.
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.

Responsibilities

Execute preventive and corrective maintenance on GMP equipment, including vial/syringe, bag filling stations, formulation, and packaging.
Identify and address 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.