Thomas P. Palka

*** ****** **** - ***** ***, Frenchtown, NJ 08825 Cell: 908-***-****

PROFESSIONAL SUMMARY

Over 20 years technical experience with the Biotechnology, Diagnostic, Medical Products, and Pharmaceutical Corporations. Very knowledgeable with the calibration of pharmaceutical and manufacturing process equipment, and with using HART protocols. Exceptional mechanical aptitude utilized to support Engineering, R&D and Manufacturing operations. SUMMARY OF SKILLS & TRAINING

Microsoft Office Blue Mountain (Calman) Procal

Project Management cGMP/ISO 9001 Clean Room Operations

FDA Basic Microbiology Lockout & Tag out Training

SAP Training Aseptic Training Maximo Training

Ark Flash Protection Training

Palltronic & Millipore Filter

Integrity Testing

Allen Bradley SLC 500 & RS

Logix 5000

Code of Federal Regulations –

21 CFR Part 11

Blood Borne Pathogens and

STOP Safety Training

Validation Requirements &

Practices

Siemens SIMATIC

Honeywell Master Logic 200

series

EXPERIENCE

09/2018 to present Consultant - I&E Technician

Industrial Staffing - Primus Green Energy - East Brunswick, NJ

● Monitor and verify all instrumentation responsible for the process control is operating correctly and adjust as needed

● Collect samples as needed during processing and forward to shift supervisor for testing

● Perform compressor checks and blow downs during processing and verify any abnormalities (Noises, leaks).

● Perform boiler checks through day monitoring conductivity is within range and specification

● Perform preventative maintenance on reactors changing out catalyst, replacing pneumatic valves, instrumentation thermocouples, high-pressure seals

09/2017 to 8/2018 Instrumentation Technician

GSK – West Conshohocken, PA

● Repair and calibration of process, lab equipment and utilities related to manufacturing process but not limited to; autoclaves, incubators, Rosemount transmitters, pressure transmitters, dissolved O2, cleaned steam generator, purification skids and Honeywell recorders.

● Loop and electronic calibrations performed.

● Assure that all standards used are in compliance.

● Arrange with contractors, Quality, Production, Facilities, Utilities, and Engineering/R&D personnel prior to any work being performed. 07/2016 to 07/2017 I&E Technician

Waste Management Company – Philadelphia, PA

● Performs Calibrations on a variety of equipment utilizing established test methods &/or Equipment Manuals

● Can independently test and troubleshoot some equipment for electrical problems. Able to determine interface functionality and capabilities of various Control Systems.

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● May contact vendors/manufacturers to assist in troubleshooting equipment problems.

● Documents work performed on Work Orders/Activity Reports and on Calibration Sheets.

● Performs Instrument and Electrical equipment installations, replacements, and qualifications.

● Activities may include modification of electrical systems. 12/2014 to 3/2016 Electro-Mechanical Instrumentation AECOM - Pfizer Worldwide R&D – Pearl River, NY

● Perform pressure, ph, temperature and flow calibrations. Examples of calibrations on air handling systems, refrigerators, incubators, centrifuges and fermentors.

● Perform PM’s and repairs on laboratory instruments as needed.

● Enter all data using Electronic Asset Management System

● Troubleshooting and repairing 480VAC 3 phase motor controls as well as 120VAC control circuits

08/2014 to 10/2014 Consultant – Electro-Mechanical Instrumentation The Franklin Company - Air Liquide – Broomall, Pa

● Perform high pressure transducers calibrations on gas mixing stations.

● Perform parameter captures on all pressure and temperature controllers.

● Perform preventative maintenance on vacuum pumps and repairs as needed.

● Work with Electrical Engineering on special projects assigned by Plant Manager to be completed by end the quarter.

● Clean manifold and rebuild gas mixing valves.

● Enter finished work orders into CMMS database (Maximo). 05/2014 to 06/2014 Consultant – Maintenance Mechanic Aerotek Commercial - MedImmune – Wayne, Pa

● Repair of packaging line equipment (syringe filling).

● Work with Engineering to resolve complex problems utilizing a high speed resolution camera and make necessary adjustments or repairs 04/2013 to 03/2014 Consultant – Senior Calibration Technician Xybion Corporation - Merial – Morris Plains, NJ

● Repair and calibration of process, lab equipment, utilities and facilities, related to manufacturing process but not limited to, autoclaves, incubators, Rosemont transmitters, pressure transmitters and Honeywell recorders.

● Loop and electronic calibrations performed.

● Assure that all standards used are in compliance.

● Arrange with R&D personnel prior to any work being performed, utilizing Procal Database.

02/2013 to 04/2013 Maintenance Mechanic

Ranbaxy Inc. – New Brunswick, NJ

● Perform and execute scheduled and unscheduled repairs and preventative maintenance for all process equipment, utilities, facilities equipment, and air handling units.

● Assist external contractors to complete their PM’s for respective systems/equipment.

● Troubleshooting and repairing 480VAC 3 phase motor controls as well as 120VAC control circuits.

07/2012 to 10/2012 Consultant – Calibration Specialist Javan Engineering – McNeil CPC -Ft Washington, PA

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● Establish a calibration program by reviewing all newly installed instruments and verify information such as; serial numbers, manufacturer’s information and input this data into the database.

● Establish operations tolerances by using manufacturing data instrument tolerances.

● Work with Process Engineering to establish process tolerances. 06/2009 to 07/2012 Instrumentation Technician

ImClone Systems Inc. – Branchburg, NJ

● Repair and calibration of process, lab equipment and utilities related to manufacturing process but not limited to; autoclaves, incubators, Rosemount transmitters, pressure transmitters, dissolved O2, cleaned steam generator, purification skids and Honeywell recorders.

● Loop and electronic calibrations performed.

● Assure that all standards used are in compliance.

● Arrange with contractors, Quality, Production, Facilities, Utilities, and Engineering/R&D personnel prior to any work being performed. 03/2009 to 06/2009 Engineering Technician

Delavau – Philadelphia, PA

● Inspect facility related manufacturing support systems on a daily basis.

● Set-up, adjust, repair, and maintain all compression and coating equipment in accordance with diagrams, sketches, operation manuals, and manufacturer’s specifications, machinery and mechanical equipment, such as engines, motors, pneumatic tools, conveyor systems, and production machines and equipment, using hand tools, power tools, and precision measuring and testing instruments.

10/2006 to 01/2009 Consultant – Senior Calibration Technician System One/Hudson – Lansdale, PA

ImClone Systems Inc.

● Repair and calibration of process, lab equipment and utilities related to manufacturing process such as; autoclaves, incubators, Rosemount transmitters, pressure transmitters and Honeywell recorders.

● Loop and electronic calibrations performed.

● Assure that all standards used are in compliance.

● Arrange with contractors, Quality, Production, Facilities, Utilities, and Engineering/R&D personnel prior to any work being performed. Actavis

● Calibration data template design utilizing the Blue Mountain Data Base and Historical Calibration Documentation. Along with instrumentation specification sheets.

● Extend calibration intervals by reviewing prior calibration records and initiating change controls.

● Responsible for the calibration of manufacturing, and R&D equipment, calibration and maintenance of waste water system within the facility service department.

06/2006 to 08/2006 Project Specialist

Accumed – Lawrenceville,NJ

● Work with engineering on the purchase of new equipment.

● Evaluate processing equipment to be installed before and after purchase. Thomas P. Palka 4

● Work with engineering on installation of equipment according to IQ validation protocol.

● Perform OQ validation and adjust according to the company’s needs for processing.

● Train operators on the safety and procedure of new equipment and process qualification.

03/2006 to 05/2006 Consultant – Maximo Consultant Specialist Kelly Engineering Resources – Bristol Meyer Squibb - New Brunswick, NJ

● Verification and determination of data and engineering specifications according to P&ID for all the mechanical and manufacturing equipment in the pilot plant and research areas.

● Collecting technical data in the field and extracting data from vendor documentation to provide equipment data input for the Computer Management and Maintenance System (Maximo Software) database according to FDA, and cGMP.

10/2005 to 01/2006 Consultant – Validation Specialist MedFocus – Sanofi Pasteur – Chicago, IL

● Responsible for the validation of process, facilities and equipment. 10/2002 to 12/2004 Instrument Engineer

Par Pharmaceutical – Spring Valley, NY

● Responsible for the calibration of manufacturing equipment, R&D, Quality Assurance and Quality Control.

● Assist in-house engineer with validation studies on manufacturing equipment.

● Assist maintenance department when needed, with mechanical troubleshooting and repairs.

● Update calibration SOP’s.

03/2002 to 10/2002 Consultant – Validation Technician Joule Technical Staffing – Schering-Plough - Edison, NJ

● Assist in Validation Department with review and updating validation protocols.

● Perform validation IQ, OQ, PQ, cleaning, computer, and process validation within granulation, coating and LOC departments.

● Worked with operators in performing W.F.I. validation transfer from department to department and in taking samples over 36 hours.

● Perform as well as supervise operation personnel.

● Worked on summary reports and closeout.

● Review with department supervisor SOP’s and update as needed. 09/1997 to 10/2001 Consultant – Maximo Consultant

Kelly Engineering Resources – Merck & Company - New Brunswick, NJ

● Verification and determination of data and engineering specifications for all the mechanical equipment on site, located in manufacturing, pilot plant, research areas, and in office buildings.

● Collecting technical data in the field and extracting data from vendor documentation to provide equipment data input for the Computer Management and Maintenance System (Maximo Software) database according to FDA, and cGMP.

Ortho Clinical Diagnostics – Electro-Mechanical Consultant

● Make necessary adjustments and repairs to minimize downtime.

● Perform all duties as described in the Preventive Maintenance Program.

● Follow instructions and prints from Manager, group leaders, or engineers to maintain repair, install, or alter production equipment.

● Operate production equipment after PMs, repairs, and adjustments to ensure machine is operational.

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03/1997 to 09/1997 Consultant – Instrument Calibration Technician Aerotek Staffing – Schering – Plough - Parsippany, NJ

● Perform calibration and repair of lab equipment and utilities related to process.

09/1981 to 09/1997 Johnson & Johnson Family of Companies – New Brunswick, NJ Ortho Clinical Diagnostics

● Senior Pilot Plant Operator – R&D (11/87 to 9/97) Devro Inc.

● Senior Laboratory Technician – R&D Pilot Plant (11/86 to 11/87) Johnson & Johnson Dental Products

● Primary Technician (5/84 to 11/86)

McNeil Pharmaceutical/J&J Baby Products

● Processing Technician (9/81 to 5/84)

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