Felipe Galan

** ********* ******

Edison, NJ ****7

Cell phone: 732-***-****

E-Mail: ad138s@r.postjobfree.com

GMP/Aseptic Electro-Mechanical Expertise- I/E Specialist- Industrial Maintenance Summary: I have 30+ years experience in industrial maintenance and instrument/electrical fields with approximately 12 years being involved in all facets of a pharmaceutical/medical device manufacturing environment. My expertise is low voltage and high voltage electrical systems, instrumentation and calibration. I have experience with installation, troubleshooting/repair and maintenance in these surroundings. I understand the rigors of not only performing a task/project correctly but also documenting work in a fashion that is clear and concise since it is subject to FDA inspections. Realize the critical importance of developing relationships both inside and outside Facilities Engineering for the plant to be successful. I am interested in a 1st shift role but will work evenings and weekends as required by the company. Key Competencies:

• Ladder logic drawing proficiency

• CMMS and manual documentation

• Electromechanical pharmaceutical equipment

• Aseptic Gown Qualified

• Blue Mountain (Calibration Software)

• Building Automation System (BMS)

• Small and large company pharma facility experience

• Critical Utilities Savvy (WFI, Comp. Air)

• Calibration • PLC and low voltage electronics troubleshooting

• High/Low Voltage Installation Work

• Highly knowledgeable in Switchgear, MCC,

Generators, UPS

• Building Management System (BMS) Expertise

• Teamwork oriented, highly conscientious

• Modifying and following SOPs

Experience:

Renaissance Lakewood LLC. Lakewood, NJ 2015 – Present Facilities Supervisor

• Direct supervision of maintenance mechanics, janitorial staff and contractors for a 400, 000 sf. Campus consisting of 6 buildings and multiple cleanrooms class A, B, C, D. Responsible for the HVAC, Pest Control, and equipment maintenance calibration programs.

• Highly experienced in CMMS maintenance systems (Infor and Blue Mountain) and Trackwise quality systems for change control, CAPA’s and deviation investigations.

• Install, troubleshoot, and maintain GMP validated equipment for production lines and critical utilities. Medtronic, Inc., Eatontown, NJ 2007 – 2015

Lead Electrician/Calibration Maintenance Technician

• Install, troubleshoot, and maintain both high and low voltage systems in a GMP aseptic environment. Developed expertise in both process and facility based systems (including, but not limited to, RO/WFI water system, lyophilizers, autoclaves, packaging machines, HVAC, wastewater treatment, high pressure boilers, chillers, critical utilities.)

• Assisted in the development of key user and functional requirements for new equipment and systems coming on site to ensure equipment can be maintained.

• Strong maintenance experience with substations, generators, MCCs, UPS, lighting and site distribution panels including infrared analysis and lubrication of switchgear. Run conduit and wire as well as built panels for smaller installations such as a waste process water pumping station.

• Well trained in Good Documentation Practices. Accustomed to and excel in a cGMP regulated environment regarding documentation such as Preventative Maintenance and repair work orders, calibrations, Out Of Tolerance (OOT) Forms, and deviations. Contributed key information for Investigations and CAPAs.

• Extensive background in the low voltage realm troubleshooting PLCs as well as hardwired systems that includes relays, power supplies, contactors, and motor starters for different types of process and facility equipment in a GMP environment.

• Started as a maintenance technician performing electrical and non-electrical tasks. Received 2 promotions in a 6-year timeframe. Currently, have 1 direct calibration report and contracting force varying from 3-5 personnel.

• Aseptic gown qualified for up to an ISO Class 5 environment (equivalent to an EU Grade A cleanroom).

• Since 2012, was promoted to oversee and execute the Eatontown Calibration program personally performing over 1,200 calibrations out of 3,000 calibrations annually. In addition, there were responsibilities for the generation/ presentation of program metrics, scheduling of specialized calibrations and upkeep of the calibration software system (Blue Mountain). Presented requested information for audits including FDA Regulatory Inspections.

• Implemented Change Controls for new projects and new instruments to be installed at the site. Edwards and Kelsey, Inc. 2002 - 2007

Sr. Electrician

• Electrical troubleshooting and installations of cellular phone towers including low voltage transmission circuitry as well as overall high voltage to provide the tower with power.

• Install and maintained the generators, UPS/DC batter backup and performed HVAC repairs in the towers.

• Interfaced extensively with management and overseeing bodies to ensure work was being performed correctly, on schedule and under-budget.

E-Tech, Fords, NJ 1999 - 2002

Sr. Electrician

• First exposure to a cGMP environment. Worked near exclusively for pharmaceutical oral solid dosage facilities. Performed project and maintenance work as assigned by supervisor.

• A main project was to install new switchgear associated with the upsizing of a site transformer from 1,000 kVA to 2,500 kVA.

• Performed electrical install, troubleshooting and maintenance on processing equipment such mix tanks, granulators, fluid bed dryers, mills, blenders, tablet presses and coating pans. Also, on facility items such as oil-less air compressors, USP Purified Water Systems and HVAC.

• PLC troubleshooting on different pharmaceutical and utility equipment systems in order to resume operation.

• Performed PM work orders as given by a CMMS as well as more manual documentation systems. Education:

• HS Diploma- Middlesex County Vocational High School with emphasis on Electrical Trade and Boiler Operator Trades Training/Computer Skills:

• Allen Bradley PLC training, Blue Mountain Calibration Software, CMMS (PMC), JCI Building Management System, Agile

(software to manage Change Controls), SABA (GMP training software), MS Outlook, MS Excel, MS Word

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