Job Summary - a concise overview of the job
The Maintenance Technician position will assist in performing corrective and preventative maintenance procedures for plant utilities and 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 coordinating maintenance with support from contract services. This position supports the Horsham manufacturing facility and labs, Horsham warehouse, and the Rye manufacturing facility.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Horsham and Rye Facilities.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
GMP Maintenance, Repair, & Facility Support
· Operate, maintain, and repair plant utilities as follows: Air handling equipment and systems; Air conditioning and 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; Natural gas systems; USP Purified Water and Water for Injection (WFI) generation and distribution systems; Clean steam generator and clean steam systems; Plant sewer and waste neutralization systems.
· Perform maintenance and escort contractors as needed.
· Perform maintenance and repair of major laboratory equipment and GMP manufacturing equipment
· Initiate purchase requisitions for materials needed for repair, PM, or consumed during the performance of duties.
· Support preventative maintenance activities as defined by specific equipment requirements.
· Cross train and serve as back-up for routine facility maintenance activities including hazardous waste collection, daily boiler chemical treatment and chemical additions, etc.
· Operate the Siemens and Johnson Controls Building Automation Systems.
· Support Calibration program by assisting calibration personnel as needed.
· Assist with daily monitoring of critical and plant utilities serving the GMP manufacturing plant.
· Assist in troubleshooting mechanical and automated equipment issues to ensure optimal functionality while adhering to cGMPs.
· Attend training seminars and courses as required.
· Member of the Safety Committee.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ 2 year Degree, technical school degree or equivalent experience. High school diploma or equivalent required.
§ HVAC Repair Training preferred.
§ General electrical wiring/installation training, preferred.
§ Minimum 2 years’ experience as a Maintenance Mechanic, Facilities Technician, or with an equivalent trade.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Experience working in a GMP environment and completion of GMP documentation.
§ OSHA safe work practices.
§ Building Management System Experience (Siemens, Johnson Controls) a plus.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Good troubleshooting skills- electrical / mechanical.
§ GMP documentation skills.
§ Must be able to coordinate multiple contract services simultaneously.
§ Good communication and organizational skills.
§ Proficient in all Microsoft Office applications.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ 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.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.