Maintenance Technician, Process Equipment (# 318, # 605)

About the role

The Maintenance Technician, Process Equipment is responsible for driving compliant results in a GMP pharmaceutical manufacturing environment by directly supporting a wide range of service disciplines covering pharmaceutical process equipment such as, but not limited to: fill lines, isolators, parts washers, autoclaves, container closure processing equipment, formulation vessels, labeling equipment, and various lab equipment utilized in the production environments. The Maintenance Technician, Process Equipment, operates in a highly technical environment that requires experience specifically in maintaining safe and reliable production activities.

Responsibilities

• Support the day-to-day production activities in the production area. First line of response in case of production equipment malfunction.
• Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.
• Partner with engineering, calibration, and spare parts teams to ensure proper inventory of key spare parts.
• Partner with engineering in the development and/or revision as required, of preventive maintenance (PM) instructions of production equipment.
• Support the coordination and execution of calibrations and preventative maintenance activities.
• Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors as needed to reach problem resolutions.
• Proactively work with supports teams Ein developing solutions for equipment issues.
• Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner.
• Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).
• Collaborate with Manufacturing, Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
• Support the onboarding and technical training of Manufacturing staff on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and formulation vessels.
• Assist R&D and MSAT on new product introduction and technology transfer activities.
• Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.
• Able to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.
• Periodically on call to monitor and respond to manufacturing equipment repairs and issues.

Qualifications

• High school diploma with 4 years of experience in executing maintenance to manufacturing equipment, or an associate’s degree or higher in Pharmaceutical Sciences, Engineering, or a related field is preferred.
• Experience with sterile fill-finish manufacturing.
• Knowledge of GMP, regulatory requirements, and industry best practices.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Experience in a continuous process improvement environment, including change management.
• Experience in using Computerized Maintenance Management Systems.
• Strong communication and collaboration skills, committed to meeting high-quality standards.