Position Summary

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 requiring experience related specifically to maintaining safe and reliable production activities. The Maintenance Technician, Process Equipment applies critical thinking and considers all business impact aspects before taking job-related actions that could cause unwanted consequences such as unsafe events, equipment failure and other risks. The Maintenance Technician, Process Equipment is 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 and driving a positive team culture.

Essential Duties and 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.

· Is on call periodically to monitor and respond to manufacturing equipment repairs and issues.

· Other duties as assigned.

Basic Qualifications (Knowledge, skills, and abilities)

· High school diploma with 4 years of experience as 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.

Preferred Qualifications

· 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.

Physical Demands and Work Environment

The physical demands described here represent those that an employee must meet to perform the essential functions of this position successfully. Reasonable accommodation

may be provided to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee must frequently use hands or fingers to handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an equal opportunity employer, a drug-free workplace, and complies with applicable ADA regulations.