Senior Validation Engineer

Validation Specialist ****-****

Joseph D. Justice

Served as Subject Matter Expert (SME) for packaging

systems.

Packaging team core member. Team made up of

*** ******* ***** • Clayton, North members from related key areas to study packaging needs

Carolina 27520 and concerns Participated in all phases of validation: Wrote

Cell 919-***-**** • Home (919) 205- and executed validation documents to support FAT, URS,

0999 FRS, PVP, and TM activities.

********@*****.*** Wrote and reviewed validation (IOPQ) documents

(protocols, reports, risk assessments, etc.).

Executed approved protocols and generated final

summary reports for utility systems, fill volume spreadsheets,

case packers, cartoners, labelers, printers, bottle washers,

SUMMARY

stopper washers, cappers, refrigerators, sterilizers, coolers,

freezers, laboratory ovens, and incubators.

A highly skilled professional with over 9 years’

Performed periodic reviews on existing equipment.

experience in validation. Expertise in writing,

Determined risk of any gaps found during review.

review, protocol execution, decision making,

Performed annual periodic performance qualifications

planning, and leadership. Knowledgeable in

on bottle washers, steam sterilizers, freezers and coolers.

FDA and cGMP regulatory compliance

Performed cleaning validation sample swapping and

requirements. An adaptable and performance-

visually inspected product-contact surfaces.

driven team player who delivers substantial

Conducted the remediation of existing equipment to

contributions to the long-term success of a

ensure that commodity, equipment and processes are

business. Excellent interpersonal skills and

validated.

ability to work well with others. Balances

Compared results against acceptance criteria and

concurrent projects to deliver results within set

brought exceptions and deviations to management's attention.

time frames and exceed expectations.

Reviewed validation packages for completeness,

SUMMARY OF QUALIFICATIONS accuracy, compliance with validation policies and

procedures.

Protocol Development Initiated necessary improvements or corrections to local

site and corporate Standard Operating Procedures.

Protocol Execution

Reviewed and revised plant and equipment drawings as

Project Management

needed.

cGMP

Interacted with QA, Engineering and Manufacturing

personnel to coordinate validation activities.

EXPERIENCE

Thermal mapped equipment using Mesa DataTracers,

GE Kaye ValProbes or GE Validator 2000.

COMPLI, LLC, Baltimore, Maryland

Johns Hopkins Bayview Medical Center –

UNDERWRITERS LABORATORIES, INC., Research

Center for Translational Molecular Imaging

Triangle Park, North Carolina

Senior Validation Engineer August 2014 –

Project Handler 2001-2004

Present

Initiated and handled engineering projects to determine

Commissioning of electrical system,

if consumer products, submitted for UL Listing, met UL and

gas systems, steam system, chilled water

international safety standards. Evaluated mechanical and

system, domestic water, sanitary and

electrical circuit designs as well as material selection for

emergency generator for imaging and

possible electrical shock and fire hazards.

research facility.

Determined project cost, time, and sample requirements

Wrote and executed installation and

by analyzing client input, supplemental data, and product

operational verification commissioning

construction. Served as client contact to discuss technical

protocols.

issues, UL procedures and requirements.

Served as project lead to coordinate

Wrote UL and international safety compliance reports,

with hospital management, site contractors

descriptions and follow-up procedures.

and other qualification staff to keep project

ADDITIONAL EXPERIENCE

on target and within budget.

YORK LABEL, INC., York, Pennsylvania 1997-2001

HOSPIRA, INC., Clayton/Rocky Mount,

JUSTICE INKJECT SERVICES, New Oxford,

North Carolina

Pennsylvania 1994-1997

VIDEOJECT SYSTEMS, INC., Raleigh, North Carolina

1991-1994

•

Field Service Engineering Industrial Electronics Certificate, Harrisburg Community

Installation, troubleshoot and repair of

College

packaging industry equipment. • Videojet Inkjet Printer Systems, Certified Technician

Electrical, mechanical, PLC and

• Label-Aire Labeler, Certified Technician

computer software related issue repairs.

• CTM Labelers, Certified Technician

Customer training on operation and

• Quadral Labelers, Certified Technician

maintenance of equipment.

• Foxjet Inkjet Printers, Certified Technician

Extensive service in the package

industry.

• Sato Thermal Transfer Printers, Certified Technician

Equipment serviced included Labelers,

• Tec Thermal Transfer Printers, Certified Technician

Inkjet Coders, Conveyors, Cartoners,

• Zebra Thermal Transfer Printers, Certified Technician

Thermal Transfer Printers and Vacuum

• Wafer Fabrication Certificate, Durham Technical College

Packaging Machines.

• Epson Computers and Printers Service Certificate

MILITARY EXPERIENCE

UNITED STATES ARMY, Garlstedt, Germany,

1985 to 1987.

UNITED STATES ARMY NATIONAL

GUARD, Dunbar, West Virginia, 1983 to 1985.

EDUCATION

NATIONAL INSTITUTE OF TECHNOLOGY,

Cross Lanes, West Virginia

Associate’s Degree, Electronic

Engineering Technology, 1990

SKILLS and ACHIEVEMENTS

• Proficient in MS Word, MS Excel, MS

Project, Outlook and many other software

programs.

• Electronic skills include the use of

digital multi-meters, amp-meters,

oscilloscopes, soldering and schematic

reading.

• Numerous Perfect Attendance and Extra

Effort Awards.

• Excellent written, verbal and time

management skills.

• Excellent interpersonal and team player

skills.

CERTIFICATIONS and SPECIALIZED

TRAINING

• Kaye Validator 2000

• Kaye Val Probes

• Mesa DataTracers

• Validation Documentation, Johnston

Community College

• Technical Writing, Johnston

Community College

Contact this candidate