Maintenance Technician, Process Equipment (#604)

Civica Rx•Petersburg, VA

19h

About The Position

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. The Maintenance Technician, Process Equipment, applies critical thinking and considers all business-impact factors before taking job-related actions that could lead to unintended consequences, such as unsafe events, equipment failure, and other risks. The Maintenance Technician, Process Equipment, should be able to apply independent judgment and perform in a small-company environment where rapid changes occur. The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive mindset, driving a positive team culture. This position follows a 2-2-3, 12-hour day schedule: 6:00 AM-6:30 PM - 2 days on, 2 days off, 3 days on, 2 days off, 2 days on, 3 days off.

Requirements

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.

Nice To Haves

Knowledge of high-speed aseptic filling and isolator barrier system technology.
Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
Proficiency in Microsoft Office Suite.

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.
Ability 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.
Other duties as assigned.