1. Matthew (Mieczyslaw) Zak
47 Cheri Lane, Fairfield, NJ 07004 ♦ (201) 953-0072 ♦ matthewzak4@gmail.com
SUMMARY
Experienced and self-motivated Maintenance Specialist with more than 25 years’ experience in an
production/manufacturing environment, including 15 years in the Life Sciences industry. Experience with solid dose,
liquid fill, and injectable drugs, both Rx and OTC. Strong planning, organizational, and management skills to minimize
equipment downtime and maximize efficiency. Proficient in calibration and validation. Subject Matter Expert who has
been described as “the most knowledgeable person on most of the equipment” by upper management. Analytical
troubleshooter with ability to identify problems and to conceive and implement creative and practical solutions.
SKILLS
Working knowledge of pharmaceutical FDA Part 11, cGMPs, OSHA, NFPA 70E Electrical Safety
and NFPA 70B Electrical Maintenance
(BMS) Schneider Electric Andover Continuum Building Management Controllers
Continuous Improvement and Operational Excellence (OpEx)
Familiar with Resource Conservation & Recovery (RCRA),Stormwater Pollution Prevention (SWPPP), Spill
Prevention Control & Countermeasures (SPCC) and hazardous material transport (DOT IATA)
Trackwise , Ariba, SAP,Oracle, WebNow,ISNetwork,
CMMS – Infor10/DataStream Maintenance Management Software
Proficient with Windows, Networking and MS Office product
WORK EXPERIENCE
Maintenance Specialist
TEVA Pharmaceuticals (previously Barr Laboratories), Pomona, NY December 2001 – present
Develop and schedule equipment Preventive maintenance (PM) tasks and Lockout/Tagout (LOTO) procedures.
Supervise maintenance team members by scheduling and prioritizing work within the team to control workflow,
ensuring the successfulcompletion of various projects. Working towards process improvement and cost savings.
Handling multiple projects from manufacturing, sterilization, engineering, and R&D departments. Working
independently or in teams to contribute to a positive work environment.
Investigate Incident Reports and document findings; use PFMEA to identify root cause and recommend
corrective and preventive action.
Schedule and coordinate contractors/vendors during project implementation and regulatory certifications for
plant mechanical infrastructure equipment. Facilitating on-site contractor EH&S and GMP training.
Extensive experience with lyophilization, sterilization, refrigeration, HVAC, boilers, facility equipment,
pharmaceutical manufacturing equipment (injection molding, coating, compression, encapsulation and
granulation equipment, motors, valves, mechanical switches, vacuum systems), electrical equipment and
laboratory equipment.
Provide maintenance representation and support during the design and implementation phases of plant
modifications, expansions or projects.
Local subject matter expert for CMMS system.
Responsible for maintenance change management using Trackwise.
Adhering to SOPs (standard operating procedures), cGMP, FDA, OSHA,EPA and company procedures.
Work closely with Continuous Improvement and Operational Excellence (OPEX) initiatives in order to enhance
efficiencies of facility while reducing costs.
Responsible for maintaining spare parts inventory.
Analyze new and existing equipment, recommending and performing equipment modifications as needed.
Provide mechanical and electrical engineering support as required during validation of equipment or systems.
Support validation of systems IQ,OQ, and PQ to assure compliance in all manufacturing and support areas.
Programming PLCs and VFDs (variable frequency drives). Calibrating instruments necessary for GMP
production.
Respond to plant emergencies and weather related events as needed.
Member of EH&S for Pomona facility.
Member of Medical Emergency Response Team.
2. Machinist/Maintenance Mechanic/Inventory Specialist
Recycle Paper Board, Clifton, NJ May 1996 – December 2001
Directly involved in the design, fabrication, and installation of additional wet stock machine.
Created prints and custom fabrication parts for heavy industrial paper mill equipment.
Examining machines and mechanical equipment to diagnose source of trouble.
Performing all necessary repairs for the facility, including mechanical, electrical, and support equipment repairs.
Keeping an accurate log and ordering machine parts and production supplies for the entire facility.
Tool Maker 1993-1996
DTM, Clifton, NJ
Making quick-change tool posts and holders for lathe applications.
Computing dimensions, plans layout, and determines assembly method and sequence of operations.
Machinist 1990-1993
Clifton Fluid Power, Clifton, NJ
Fabricating custom hydraulic pressing machines.
Setting up and operation of lathe, milling, drilling, grinding, and welding machines.
CERTIFICATIONS
Occupational Safety and Health Administration Certification in General Safety & Health, May 2005
Operation and Routine Maintenance compromising Solar Centaur 50 Gas Turbine Generator Sets, May 2001
AC Drives Application and Maintenance, Advanced Electrical Training, February 2004
Rockwell Automation - Programmable Controller PLC-5/SLC 500 Fundamentals of RSLogix, June 2005
Rockwell Automation - SLC 500 Programming, June 2005
ISA -Installing, Calibrating, & Maintaining Electronic Instruments, October 2008
EDUCATION
Technikum Elektryczne, Nisko, Poland, 1984-1989
Concentration in Electromechanical Engineering
Bergen County Technical School, Hackensack, NJ
Certification in Electrical Circuits I, Fall 2002
Certification in Electrical Circuits II, Spring 2002
Certification in Motors and Generator Control Circuits, Fall 2003
Certification in Motors and Generators, Spring 2003
Certification in Programmable Controllers Advanced, Fall 2004
Certification in Programmable Controllers, Spring 2004
Certification in PC – PLC Control, Spring 2005
Certification in Fireman, Low Pressure Black Seal, Spring 2008
References available upon request.