Mechanic II, Maintenance (DPI)

United Therapeutics•Rtp, NC

11h•Onsite

About The Position

The Mechanic II, Maintenance is primarily responsible for timely completion of preventive maintenance, intermediate level troubleshooting, and highly effective repairs of GMP manufacturing equipment, clean utilities, and all associated support systems. Manufacturing equipment may include but is not limited to bioreactors, blow-fill-seal machines, autoclaves, fluid bed processors, pan coaters, tablet presses, robotic aseptic filling lines, aseptic vial filling lines, automatic visual testing equipment, etc. (relative to specific site operations). This role will also support monitoring & maintaining all base utilities, buildings, electrical systems, water systems (incoming, pure, & waste), steam systems, HVAC & refrigeration, Life Safety Systems, and grounds as necessary in a cGMP Facility.

Requirements

H.S. Diploma or General Education Degree (GED)
4+ years of experience as maintenance personnel in an industrial, pharma/bio, or manufacturing environment
Active Driver License, valid and in good standing
Intermediate knowledge of cGMP and ISO regulatory requirements
Intermediate ability to troubleshoot systems and components to ensure the safe and proper operation and adherence to building and local codes
Intermediate ability to work independently on projects or assignments without close supervision or detailed instructions to maximize workplace productivity
Ability to maintain records and reports (e.g., time sheets, daily work orders, time reports) to provide information and documentation and to comply with departmental policies
Ability to work in an environment that includes dust and other debris using Personal Protective Equipment (PPE) in the installation, maintenance, alteration, and repair of building/facility systems
Ability to adhere to all regulatory and compliance requirements defined in Good Manufacturing Practices (cGMPs)
Willingness to learn new concepts to fully understand aseptic technique and demonstrate proper cleanroom behavior
Ability to follow and execute Standard Operating Procedures (SOPs)
Fundamental computer skills and ability to use tablet devices
Intermediate understanding of equipment and methods of operation, including but not limited to: manufacturing/process equipment, BMS/BAS, fire/life safety, purified water, environmental monitoring, and other systems

Nice To Haves

Associate degree in advanced technical training
4+ years of experience in the pharmaceutical/medical device industry (preferred)

Responsibilities

Ensure production and facility systems operate efficiently and properly by following established processes and monitoring and inspecting equipment and facilities
Complete assigned preventive and corrective maintenance activities and accurately document work performed in the computerized maintenance management software (CMMS) in accordance with policies and instructions
Troubleshoot equipment and perform effective repairs on manufacturing equipment and associated support systems and utilities with limited supervision
Assist with monitoring and maintaining boiler system operations, including chemical testing and charging brine tanks for feed water softeners as assigned
Escalate and seek guidance on the most complex tasks and projects when needed to complete work safely and effectively
Adhere to applicable standard operating procedures (SOPs) and attend and fully participate in all assigned training
Maintain facility and production systems in accordance with applicable cGMP requirements
Ensure that vendors and contractors are trained in applicable company procedures regarding safety, environmental, and health in order to provide effective service in compliance with all ordinances such as electrical and construction codes
Assist with special projects and construction projects, which may include demolition, renovation, and new construction
Participate in emergency and after hours on-call rotation in order to ensure continuous operations of facility and production systems
Perform other duties as assigned