The Facilities Engineer provides total maintenance support for the Anasco, P.R. facility to ensure maximum operational potential and equipment & utility up time. Responsible for working hands-on with maintenance personnel, administering plant wide preventive maintenance programs and ensuring all maintenance activities are completed safely within OSHA and internal standards. Develop strategies to improve overall reliability and safety of plant, personnel and production processes. Respond to breakdowns, diagnose faults and oversee time-critical repairs.  Plan and oversee execution  of routine maintenance of plant, equipment and machinery.  Promote preventative and predictive maintenance program. Executes utilities and other equipment and system validations, including planning, protocol development and final report issuance. Will also be responsible for the set up and effective operation of CMMS (Maximo) system. Responsible for coordinating facility engineering projects including renovations and utility systems enhancements.  Uses the Facility Maintenance function to assure that the plant building and systems are effective and compliant. Interfaces with Mfg Engineering, Operations, Product Development, Quality, and Corporate Engineering as needed.

• Responsible for providing engineering support for maintenance & upgrade of existing plant, and process equipment.
• Responsible for introduction and project management of new equipments. These projects are typically high-level capital projects with increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly. Must be able to manage the project in its entirety, and be able to perform / deliver specific project tasks as necessary. Work with Management to develop capital plans for equipment replacement.
• Responsible for engineering support for maintenance, analysis, and upgrade of utility systems when needed (WFI, DIUF, HVAC, CCA, & steam generation). Includes accountability for corrective, preventive, & predictive maintenance activities.  
• Maintain, analyze, and upgrade controls and automation.
• Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. Support/execute and document NC/CAPA/OOS on equipment and facilities related investigations and corrective actions.
• Design maintenance strategies, procedures and methods
• Creates, implements, and monitors preventive maintenance work and maintenance computer programs
• Develops, tracks, and reports maintenance related matrices (OEE, MTBF, MTTR, etc). Develop/improve PM system to maximize equipment uptime and performance. Promote equipment reliability program.
• Perform Factory and Site Acceptance Test (FAT, SAT), commissioning, installation/operational qualification (IOQ) of new equipments/ systems. Support the acquisition, installation, and operation of equipment and process utilities.
• Participates in Root Cause Analysis and problem solving process.
• Identify, trend and analyze equipment & utility performance. Recommend changes and enhancements in performance, operations & plant availability.
• Uses staff to manage facility engineering related projects including renovations and major building enhancements (Clean Rooms, HVAC, etc).
• Ensure that projects are effectively coordinated in line with production scheduling and quality/compliance requirements.
• Work with leadership team regarding plans for facility renovations and utility enhancements.
• Provides consultation and support to facility and production maintenance as needed.
• Works with Engineering to implement facility capital projects as required
• Interacts with and provide Facility Project support to Corporate offices if required
• Supervises the plant maintenance function. Creates and executes plans to assure personnel job quality and accountability, as well as maximize customers satisfaction.
• Develop procedures and plans to insure compliance to Federal, State and Local regulations, including but not limited to OSHA, FDA, BSI, EPA, JCA & ADA. Support plant compliance to company EH&S policies &  procedures.
• Develop or amend procedures / plans to insure compliance to corporate and plant policies.
• Coordinate specific efforts of a project team, including the core team members (Manufacturing, Plant QA/QC/RA, Facilities, Materials Management, Engineering) and supporting members (Corporate Regulatory, Finance, etc.) as directed.
• Strategic planning to insure plans are in place to accommodate new products, and plant (or process) expansion, or modifications.
• Interface and coordinate activities with other internal departments, corporate, customers and external vendors.
• Performs other related duties as assigned.

• Bachelor's degree in Mechanical Engineering (preferably), Chemical or Electrical.
• 4 to 6 years experience in a plant maintenance position, preferably in the medical device industry to include packaging and or processing equipment. Experience in clean rooms cleaning and sanitation, refrigeration, controls, and or Lyophilization is a plus.
• Knowledge of the various types of equipment and materials used in manufacturing processes such as mixers, pumps, piping, valves, pressure vessels, tanks, sealers, hoods and Multivac packaging equipments.
• Knowledge of plant systems – water purification, steam generation, HVAC chiller and AHU, clean compressed air system and CMMS (Maximo) experience
• Knowledge of PLC & automation.
• Knowledge of Engineering Change Controls, ISO, QSR and design Control procedures.
• Demonstrates excellent organizational and communication skills (oral and written). 
• Must have demonstrated knowledge in computers and business software (MS office, MS project, Autocad).
• Project management, machine design, process improvement and reliability experience desired.