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Validation Engineer

Nanuet, New York, United States
February 02, 2018

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John Lizzo

Validation Engineer

* ****** **.

Nanuet, NY 10954

Home Phone: (845) ***-****

Cellular Phone: (845) ***-****

** *****: Pharmaceutical cGMP/ cGLP compliance projects

25 years: Hands-on engineering experience in the process industries

College degrees in Chemical Engineering and Computer Science



Installation, operational and performance qualification (IQ/OQ/PQ) protocols

21 CFR Part 11 Electronic Records / Electronic Signatures compliance

cGMP compliance of equipment, systems, utilities and facilities

cGLP compliance of laboratory equipment

Kaye Validator temperature mapping

Annual Drug Product Reviews

Validation Reviews

Change Controls


Assembly, Commissioning, Inspection and Maintenance

Chemical Processing Systems / Bioreactor Systems

Automated Control Systems (PLC’s, DCS’s)

Water for Injection (WFI) Systems

Sanitize-in-Place (SIP) Systems

Clean-in-Place (CIP) Systems

Packaging Equipment

HVAC Systems


Piping and Instrument Diagrams (P&ID’s)

Process Flow Diagrams (PFD’s)

Heat and material balances

Equipment Specifications

Process Improvements

Plant Expansions


Regeneron Pharmaceuticals, Inc. Rensselaer, NY 9/2015 to 12/2015

Engineering Compliance Specialist

Reviewed piping and instrument diagrams (P&ID’s) for bioprocess equipment for compliance to cGMP principles.

The bioprocess equipment included bioreactors, chromatography skids, media preparation tanks and clean utility distribution systems.

Zimmer Biomet Parsippany, NJ 8/2014 to 8/2015

Process Validation Engineer

Wrote and executed process qualification protocols for the manufacture of trabecular metal parts to be used in surgical implants for artificial joints.

The trabecular metal parts were for an artificial knee cap and an artificial shoulder.

McNeil Consumer Healthcare Lancaster, PA 10/2012 to 6/2013

Equipment Engineer

Produced a report on the performance of vision systems utilized on the oral solid dosage (OSD) packaging lines. The packaging lines were for OTC products manufactured at the McNeil Consumer Healthcare Facility in Lancaster, PA.

The packaging lines were for blister packages and bottles.

Merck & Co., Inc. Elkton, VA 3/2012 to 6/2012

Process Engineer

Produced documentation and procedures for a bioprocess project at the Merck Stonewall facility in Elkton, VA.

Produced a spare parts list for a tangential flow filtration (TFF) system.

Assisted with the writing of a master batch record for a cell harvesting operation.

Wrote standard operating procedures (SOP’s) for the operation of bioprocess equipment.

Johnson & Johnson Consumer Products Corp. Skillman, NJ 7/2011 to 2/2012

Technical Writer

Wrote Annual Drug Product Reviews (ADPR’s) for formulated cosmetic products and medical devices.

Shire Pharmaceuticals, Inc. Owings Mills, MD 3/2010 to 9/2010

Validation Specialist

Wrote validation reports for the facility USP Purified Water System.

Conducted reviews of validation documentation for manufacturing equipment for producing solid dosage forms.

Wrote process validation reports for processes to produce solid dosage forms.

GlaxoSmithKline Marietta, PA 7/2009 to 12/2009

Technical Writer

Wrote Standard Operating Procedures (SOP’s) for the manufacture of H1N1 vaccine at the GlaxoSmithKline facility in Marietta, PA.

EXPERIENCE (continued)

Biokinetics Inc. Branchburg, NJ 8/2008 to 2/2009

Validation Specialist

Wrote cGMP commissioning and operational qualification (OQ) protocols for bioprocess manufacturing equipment at the ImClone Systems Corporation facility in Branchburg, NJ.

Equipment qualified included bioreactors, buffer hold tanks, and associated CIP/ SIP systems.

Pharma-BioServ Inc. Fort Washington, PA 3/2007 to 4/2008

Validation Specialist

Wrote and executed cGMP installation, operational and performance qualification (IQ/OQ/PQ) protocols for manufacturing equipment in the McNeil Consumer Healthcare facility in Fort Washington, PA. The protocols were for automated equipment used to process and package OTC pharmaceuticals in liquid and solid dosage forms.

Equipment qualified included a bottle unscrambler, a cartoner, case packers, palletizers and a CIP system.

GlaxoSmithKline Collegeville, PA 4/2006 to 3/2007

Validation Analyst

Reviewed and approved cGLP validation documentation for computerized analytical equipment. Documents reviewed included validation plans, validation protocols, validation reports, risk assessments, GMP assessments, electronic records / electronic signatures assessments, and change controls. Assisted with the tracking of upgrades and improvements to computerized analytical equipment for CFR 21 Part 11 compliance.

Equipment qualified included total organic carbon (TOC) analyzers, differential scanning calorimeters, thermal gravimetric analyzers, dissolution systems, high performance liquid chromatography (HPLC) systems, spectrophotometers, and mass spectrometry systems.

Aerotek Scientific East Syracuse, NY 10/2005 to 2/2006

Validation Technologist

Wrote and executed cGMP performance qualification (PQ) protocols for equipment used for bioprocess manufacturing at the Bristol-Myers Squibb facility in East Syracuse, NY. The protocols were for steam-in-place (SIP) operations and filter integrity testing.

The PQ of steam-in-place (SIP) operations included work with set-up and operation of Kaye Validator data logging equipment for temperature mapping and bioindicator testing in piping and vessels associated with cell culture and product purification systems (fermentation tanks and chromatography buffer tanks).

EXPERIENCE (continued)

Washington Group International Princeton, NJ 6/2004 to 5/2005

Validation Specialist

Wrote and executed cGLP installation and operational qualification (IQ/OQ) protocols for laboratory equipment at the Sanofi-Pasteur facility in Swiftwater, PA. The equipment is used for vaccine testing and discovery.

Equipment qualified included high performance liquid chromatography (HPLC) systems, spectrophotometers, gas chromatography (GC) systems, liquid chromatography/ mass spectrometry (LC/MS) systems, mass spectrometry (MS) systems, capillary electrophoresis systems, bio-safety cabinets, fume hoods, high-throughput (HT) liquid handling systems (pipetting platforms), plate readers, plate washers, ultracentrifuges, laboratory refrigerators, freezers, incubators and water baths.

Jacobs Engineering Group, Inc. Indianapolis, IN 9/2003 to 4/2004

Validation Engineer

Prepared cGMP change control documentation for the upgrade and modernization of a parenteral drug manufacturing facility for Eli Lilly. Wrote change controls for product formulation tanks, compartment washers, equipment pass-throughs, unidirectional airflow (UAF) hoods, and clean air projectors.

Gavin Pharmaceutical Services Fort Dodge, IA 4/2002 to 7/2003

Validation Engineer

Wrote and executed cGMP installation, operational and performance qualification (IQ/OQ/PQ) protocols for new systems in a multi-purpose active pharmaceutical ingredients (API) manufacturing facility. Equipment qualified included a Water-For-Injection (WFI) still, a WFI distribution system, nutsche filters, centrifuges, chemical reactor systems, CIP systems, utility and HVAC systems.

Wyssmont Company, Inc. Fort Lee, NJ 10/1994 to 10/2001

Applications Laboratory Engineer 8/1999 to 10/2001

Performed drying and size reduction tests on over 100 process materials to scale-up operations to commercial scale units. Maintained laboratory equipment and set-ups.

Field Service Engineer 10/1994 to 8/1999

Assisted in the assembly, commissioning, inspection and maintenance of process drying, size reduction, and feeding equipment. Successfully completed more than 50 service assignments.

Roy F. Weston, Inc. West Chester, PA 2/1986 to 8/1986


Performed engineering and economic calculations for Phase II of the ALCOA Energy Conservation Study. The study evaluated energy conservation projects for the ALCOA North Plant boiler and utility systems in the ALCOA Tennessee Plant.

Kesler Engineering Inc. Highland Park, NJ 1/1985 to 8/1985

Process Engineer

Produced process design and specifications for a new food processing plant.

EXPERIENCE (continued)

Crawford & Russell, Inc. Stamford, CT 12/1981 to 1/1985

Process Engineer

Prepared air permit applications for pharmaceuticals manufacturing, pilot plant and waste handling operations at the Hoffmann-LaRoche Nutley, NJ plant.

Assisted with pilot plant equipment specifications and vendor evaluations for a new NDA pilot plant at the Hoffmann-LaRoche Nutley, NJ plant.

Produced process design and specifications for the Phenylalanine Recovery Units for two Aspartame plants for Searle Food Resources.

Produced process designs for the Monomer Sections of two Kynar plants for Pennwalt Corporation.

The Lummus Company Bloomfield, NJ 6/1980 to 5/1981

Process Engineer

Produced process design and specifications to obtain a total installed cost estimate for a new process to manufacture Epichlorohydrin for Ciba-Geigy Corporation.

Stauffer Chemicals Company Dobbs Ferry, NY 7/1979 to 6/1980

Process Engineer

Collected process data to assist in the debottlenecking of the Stauffer Polymers PVC plant in

Delaware City, DE.


Manhattan College Riverdale, NY 1974 to 1978

Bachelor’s Degree in Chemical Engineering GPA: 3.7/4.0

Manhattan College Riverdale, NY 1978 to 1979

Master’s Degree in Chemical Engineering GPA: 3.8/4.0

The State University of New Jersey at Rutgers Camden, NJ 1986 to 1990

Bachelor’s Degree in Computer Science GPA: 3.8/4.0

References and additional information are available upon request.

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