Utilities & Facilities/GMP Maintenance Technician II

The Utilities Facilities/GMP Maintenance Technician II will execute corrective and preventative maintenance of all critical GMP and non-critical GMP instrumentation and controls for plant utilities and GMP manufacturing equipment such as fermenters, process vessels, purification equipment, autoclaves, component washers, and other ancillary manufacturing equipment. In addition, this position will assist with troubleshooting equipment issues and with support from contract services. This position supports the Horsham manufacturing facility, labs, and GMP warehouse.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Responsibilities:

Site Manufacturing & Horsham Campus

• Responsible for maintaining the operation and Integrity of all critical utilities and GMP Equipment systems and Non GMP to include HVAC systems, refrigeration equipment and systems; Boilers (steam and hot water), plant steam, and plant hot water; Chillers and chilled water systems; Air compressors, air dryers, and compressed air systems; Nitrogen system; Domestic hot and cold water system; Purified Water (PW) and Water For Injection (WFI) generation and distribution systems; Clean steam generator and clean steam systems; Plant sewer and waste neutralization systems.
• Perform Preventative and Corrective maintenance of GMP Manufacturing Equipment, Lab, and warehouse equipment in accordance with ENDO Engineering standard Operating Procedures.
• Respond to building / security and GMP Equipment alarms 24 hours per day, 7 days per week plus occasional emergencies. Individual will be part of the on-call rotation and will be required to respond to off-hours alarm per the department schedule.
• Develop and/or revise Standard Operating Procedures (SOPs) for preventative maintenance of Critical Utilities, and GMP equipment supporting GMP Manufacturing operations as required.
• Provide daily monitoring of the Siemens and Johnson Controls Building Automation Systems and respond to system issues and critical alarms in a timely manner in order to reduce impact of system failures.
• Provide Daily walk throughs and monitoring of critical utility areas serving the GMP manufacturing and warehouse facilities.
• Assist in troubleshooting mechanical and automated GMP equipment issues to ensure optimal functionality while adhering to cGMPs.
• Schedule maintenance contractors as required and supervise onsite work.
• Responsible for timely and accurate closeout of Preventative and Corrective maintenance work orders in the Computerized Asset Management System (CAMS).
• Assist in the identification and purchase of spare parts using COUPA
• Attend training seminars and courses as required.

Qualifications:

Education & Experience

• 2-year technical school degree or equivalent experience. High school diploma or equivalent required.
• HVAC Training preferred.
• General electrical wiring/installation training preferred.
• Minimum 3 years’ experience as a Maintenance Mechanic, or with an equivalent trade.
• Experience working in a GMP environment and completion of GMP documentation required.

Knowledge

• Experience working in a GMP environment and completion of GMP documentation is required.
• Knowledge of OSHA safe work practices.
• Building Management System experience (Siemens, Johnson Controls) a plus.

Skills & Abilities

• Knowledge of electrical equipment and mechanical ability to interact with the equipment.
• GMP documentation skills.
• Must be able to coordinate multiple contract services simultaneously.
• Effective communication and organizational skills.
• Proficient in Microsoft Office applications preferred.

Physical Requirements

• Must be able to lift 50 pounds.
• Exposure to elements (i.e., hot weather, cold weather, precipitation) for brief periods.
• Operate computer-controlled equipment which requires a combination of standing, sitting, and walking to and from the operator interface terminal.
• Required to work around live electrical circuits and mechanical devices in the execution of their duties.