Site Utilities and Engineering Specialist
About the Job
Accountable for leading and coordination of the site utilities infrastructure, systems and equipment, including GMP Heating, Ventilation & Air Conditioning, (HVAC) system activities and Purified Water generation/distribution systems. Also, accountable for the plant High Efficiency Particulate Air (HEPA) filters certification program to fully comply with applicable manufacturing and regulatory requirements. This position is instrumental in improving the Utilities system of BMS’s operations, and therefore, in providing competitive advantage for our organization. Must comply with all security Guidelines, Environmental, Health & Safety regulations and the current Good Manufacturing Practices required by the job function. Administers Plant High Efficiency Particulate Air (HEPA) filters certification program to fully comply with applicable manufacturing and regulatory requirements. Assures HEPA filters certification are conducted as required by established frequencies. Documentation of HEPA filters is revised and approved by Quality Assurance, Manufacturing and Engineering Areas prior to close the certification process. Assures adequate inventory levels of HEPA filters in stock for replacement of filters as required.
Assures that the HEPA Filters certification Program Standard Operating Procedure development and/or maintenance (Assure procedure is up to date with current regulatory standards and requirements). Performs HVAC System balancing and differential pressures adjustments as required by manufacturing areas requirements and maintains all related documentation and files of all HVAC balancing, differential pressures adjustments and HEPA filters of the plant HVAC System. Defines and implements an Air Handling Replacement program and develops the required Capital Appropriation Request to replace AHU’s. Supports the maintenance personnel during HVAC system troubleshooting. Provides Subject Matter technical expertise for equipment ensuring continue compliance to regulatory company and site policy and procedures. Reviews and approves all new HVAC and PW systems’ design. Identifies and analyzes equipment and systems failure causes and develops corrective measures to avoid reoccurrence. Coordinates external maintenance contracts services and non-routine maintenance activities. Assures maintenance related documentation complies with the current Standard Operating Procedure of Good Documentation Practices. Reviews predictive, preventive maintenance Job Plans, calibration data sheets for all HVAC and PW equipment and systems to assure compliance with applicable procedures. Supports Reliability Centered, Predictive, Preventive and Corrective Maintenance activities and recommends changes or implement changes as required. Evaluates all HVAC units and PW relevant operational data, reports, statistics and documentation related to identified critical equipment and systems in order to generate proactive and timely actions to optimize availability and reliability of equipment and; prepares failure analysis reports, concentrating on identifying repetitive occurrences and take appropriate actions as needed. Evaluates HVAC equipment and PW maintenance conditions and submit recommendations to site management for improvement. Supports compliance efforts related to Deviations (QE’s), CAPA, Technical Assessments and change management. Participates in regulatory audits and SME of our GMP utility systems (HVAC and PW). Evaluates and review BMS quality directives related to our GMP utility systems (HVAC and PW). Leads and develops the BAS system requirements for HVAC monitoring. Supports energy conservation assessments and implement control changes to optimize HVAC and PW systems performance. Coordinates with Project Engineers maintenance new projects reviews to assure that new equipment and systems are design, developed and constructed following adequate maintenance practices such as adequacy of space, equipment location, materials of construction, etc. Supports other Engineering & Maintenance Department functions as required by plant needs and unplanned events.
BS Degree in Engineering. Five (5) years of experience in utilities maintenance, PW, Steam, Compressed Air, Nitrogen, and HVAC System Operation and/or HVAC System Design. Possess proven administrative and computer literacy background and abilities. Able to analyze large databases and field observations to indicate weaknesses/failures of equipment and systems. Able to communicate fluently in English and Spanish (verbal and written). Must have excellent communications, analysis, organizational and leadership skills. Ability to exercise accurate judgment and to evaluate information critically. Experience with HEPA filters certification program and with HVAC systems requirements and thorough knowledge of applicable standards and regulations. Good teamwork skills. Capacity to interact effectively with people. Able to exercise good judgment in special situations. Ability to keep work pace and/or meet deadlines. Willing to work irregular hours, rotating shifts, weekends and holidays.