Engineer Medical Device

James J. Keenan 908-***-****

** ******* **., **********, **. 08822

****************@*******.***

Objective: Senior Quality Engineer

Qualifications:

An engineer with over fifteen years of hands-on Pharmaceutical and Medical

Device industry experience in a variety of technical positions including

manufacturing, engineering, regulatory, quality, safety and environmental

compliance. Specific areas of expertise are in the implementation of Good

Manufacturing Practices, validation of pharmaceutical, biopharmaceutical,

and medical device processes. Write and execute commissioning documents,

IQ, OQ, PQ Protocols and Process Validations. Conduct validation studies on

pharmaceutical processes, medical device manufacturing, utilities,

manufacturing equipment, packaging, laboratory instruments, sterilization,

and cleaning validation. Support FDA, OSHA, and EPA regulatory compliance.

Conduct specialized training in cGMPs, and general safety procedures for

production, laboratories, clean rooms, and sterile environments. Perform

risk assessments using FMEA and FTA.

Experience: Compliance/Validation related

Integra LifeSciences Corp. Plainsboro, NJ 2008 to Present

Quality Assurance Engineer

Provide Plant Quality support for new or improved products, processes, and

equipment. Write new procedures for validation policies and develop IQ/OQ

protocol templates. Write validation protocols. Review, and approve

validations and qualifications for new and existing products, processes,

and equipment. Identify opportunities for improvement in manufacturing.

Evaluate the manufacturing facility Quality Systems. Participate in audits

from FDA and TUV. Take a leading role in the EO sterilization validation.

Ensure that projects are in compliance with cGMP, QSR, ISO, ICH or other

applicable standards. Champion the manufacturing site Validation Master

Plan and Cleaning Master Plan. Evaluate the equipment cleaning program and

make improvements through new cleaning procedurers and validations. Lead

investigations and resolutions of medical device complaints, NCRs (Non-

Conformance Reports), and CAPAs (Corrective and Preventative Actions).

Document the investigations in TrackWise. Review and determine the impact

on instrument and equipment OOT (Out of Tolerance.) Stay current on

compliance and regulatory affairs issues.

ThermoFisher Scientific (Acculogix) Bristol, PA 2007 to 2008

Validation Specialist

Responsible for managing, developing and implementing validation protocols

and test procedures to ensure products meet with appropriate regulatory

agency validation requirements, internal company standards, and industry

current practices for a clinical trial packaging company. Create and

execute qualifications and validation protocols. Assist in Quality

Assurance auditing. Oversees and reviews validation processes and

procedures. Take a leading role in the facilities and equipment CAPA

program. Supervise the site calibration program. Make recommendations for

changes and improvements. Keep current with quality and validation

practices.

Sharp Corp. Allentown, PA 2007

Validation Engineer

Develop and execute Installation (IQ), Operational (OQ), Performance

Qualification (PQ), and Packaging Validation (PV) protocols at a contract

packaging company for primary and secondary packaging lines and equipment.

Write the final summary reports, investigate exceptions and deviations.

Systems and equipment qualified include tablet filling lines, blister foil

units (bfu), powder filling lines, bottle orienter, desiccant feeder,

filling machines, metal detectors, cappers, induction sealers, labeling

machines, outserters, checkweighers, cartoners, bundelers, and case sealers

and labelers.

Atpharma Inc. Princeton, NJ 2006 to 2007

Validation Consultant

Responsible for the development and execution of Installation (IQ),

Operational (OQ), and Performance Qualification (PQ) protocols, as well as

the preparation of final summary reports in support of process, equipment,

and cleaning validations for the launch of a new product family at

Osteotech, a medical device manufacturer in Eatontown, NJ. Perform Gap

Analysis reviews on executed protocols for laboratory analytical

instruments and develop new validation protocol templates and SOPs

(Standard Operating Procedures) for a generic drug manufacturer.

Contractor, Hopewell, NJ Branchburg, NJ 2005 to 2006

Validation Specialist

Contract employee at Bristol-Myers Squibb research site in Hopewell, NJ.

Involved in the writing and executing of validation protocols for a major

modification to the site wide compressed air system. Contract employee for

RMS (Roche Molecular Systems) in Branchburg, NJ. Responsible for process

validation activities in a cGMP/CBER regulated medical device manufacturing

environment. Perform process validation activities for new and existing

products, including Enzymes, Bulk Manufacturing, Formulation, Fermentation,

and Filling and Packaging Processes. Write and review protocols, support

change control and the regulatory process. Interaction with cross-

functional teams.

Day & Zimmermann Inc. Philadelphia, PA 2004 to 2005

Validation Specialist

Responsible for writing and executing Commissioning Documents, IQ, OQ, and

PQ Protocols and Final Reports for utilities and equipment for a major

expansion of a manufacturing building at Schering-Plough in Kenilworth, NJ.

Utilities include compressed air system, USP water, Air Handling Units,

filling and packaging lines, material transfer systems, and pure steam

generation system. Wrote SOPs and Preventive Maintenance plans, and summary

reports for new equipment and systems. Perform Gap Analysis on executed

protocols for manufacturing equipment at a biopharmaceutical company,

Imclone. Make recommendations for corrective actions.

CTG, Inc. Nutley, NJ 2003

Validation Engineer

Developed Baseline reports for Hoffmann-LaRoche on status of laboratory

equipment in preparation for relocation of Quality Management department to

a newer building on the same site. Inspected equipment and determined if it

was covered by 21 CFR Part 11. Documented all available records on

calibration, maintenance, training, and SOPs for all equipment and systems

to be moved. Wrote and executed Installation (IQ), Operational (OQ) and

Performance Qualification (PQ) protocols, and prepared final summary

reports on equipment after relocation.

IPS, Inc. Hillsborough, NJ 2001 to 2003

Validation Specialist

Responsible for generation and execution of Installation (IQ), Operational

(OQ) and Performance Qualification (PQ) protocols, as well as the

preparation of final summary reports. Provide direct support in process,

equipment, utility, and cleaning validations CIP and SIP. Performed

compliance validations of USP/WFI/DI water, Compressed Air systems, clean

room facilities, HVAC and equipment including milling & sieve machines,

mixers, spray dryer with PLC system, pumps, compounding tanks, vessels with

agitators and heat exchangers in aseptic, sterile, liquid, tablet

manufacturing and tablet coating area. Redlined P&IDs, PFDs and control

instrument prints to reflect As Built situation. Compiled and modified

standard operating procedures, preventive maintenance matrix as well as

summary reports. Gathered/analyzed process manuals and FAT documentation on

equipment; implemented and resolved instrumentation calibration issues.

Performed commissioning activities in support of specific validation

projects. Familiar with the requirements of 21 CFR Part 11.

Experience: Safety/Engineering related

Formosa Plastics Corp, U.S.A., Livingston, NJ 1998 to 2000

Senior Corporate Safety Engineer

Plan, design and implement Corporate Safety programs to ensure

compliance with all applicable federal, state and corporate rules,

regulations, and policies. Lead safety and health audits of manufacturing

facilities. Develop the EPA Risk Management Program for a major

petrochemical complex. Lead HAZOP (Hazards and Operability) studies on

petrochemical facilities. Work with corporate engineering department and

outside Engineering & Construction firms during all phases of the design of

new plants and expansions of existing facilities. Investigate

incidents/accidents at plants. Create and conduct training programs.

Sika Corp., Lyndhurst, NJ 1997 to 1998

Safety Engineer/Process Engineer

Responsible for all areas of process and occupational safety at a

specialty chemical manufacturing plant. Develop and administer safety

standards, policies and procedures. Lead HAZOP studies and perform risk

analyses. Conduct all employee and contractor training. ISO 9000 team

member. Manage engineering projects up to $600,000.

Primatech Inc., Princeton, NJ 1994 to 1996

Principal Engineer

Manage process safety projects. Areas of responsibility include engineering

design reviews, hazards identification studies, risk management plans, and

risk assessments. Develop programs for client companies to be in

compliance with OSHA occupational and process safety regulations.

Conduct process hazards analysis studies (HAZOPS) for clients in specialty

chemical, pharmaceutical, petroleum refining, petrochemical, ammonia

refrigeration, and water treatment. Develop procedures for client safety

programs such as hot work permits, management of change, accident

investigations, confined space entry, lock out tag out, hazard

communication, and emergency response.

BASF CORPORATION, Parsippany, NJ 1991 to 1993

Senior Safety Engineer

Provide support to manufacturing sites and research centers on process and

occupational safety, OSHA compliance, and fire protection. Conduct safety

reviews, including process hazards analysis (HAZOPS) of new manufacturing

facilities and modifications to existing processes. Work closely with the

corporate engineering department during all phases of the design of new

plants or expansions of existing facilities. Lead environmental, health,

and safety audits of manufacturing sites and research centers. Conduct

accident investigations. Create presentations and perform training at

regional safety meetings. Set up and manage corporate safety department's

databases.

HOFFMANN-LA ROCHE INC., Nutley, NJ 1986 to 1991

Senior Safety Professional

Responsible for process and occupational safety in chemical

manufacturing facilities, research laboratories, and pilot plants. Conduct

process hazards analysis of existing and new chemical processes. Write new

corporate safety standards and policies, and revise existing ones. Conduct

OSHA compliance audits of chemical processing facilities, laboratories, and

pilot plants. Develop training programs and conduct employee training. Work

with corporate engineering department on design of new facilities and

revamps of existing ones in regards to safety and fire protection

requirements.

WITCO CORPORATION, Newark, NJ

1980 to 1985

Process Engineer

Responsible for capital projects up to $500,000. Work with corporate

engineering on projects exceeding $1,000,000. Write requests for

expenditures, deal with vendors, order equipment, and oversee installation

of equipment and start-ups. Recommend new equipment and process

improvements. Work on process optimization and troubleshooting studies.

Work on instrument problems.

Education:

Bachelor of Science, Chemical Engineering, the Ohio State University,

Columbus, Ohio

Professional Affiliations:

Member of PDA, ISPE, ASQ

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