EHS Program Mgmt, related training, risk assessment, process eng

John A. Dunn, BS ChE, MIE (Safety Engineering)

** ******* **** ****: 914-***-****

New Hampton, NY 10958 ********@*****.***

SUMMARY

Enthusiastic and results-driven Training Program and Safety and Health Professional (including FDA GMPs) with extensive experience in the development, establishment and management of Training Programs and Training Tracking Systems, Safety and Medical Surveillance Programs in the Utility, Manufacturing, Chemical and Pharmaceutical Industries. Proven record of success with Training Programs and Safety Programs at the site, division and corporate levels. Principle strengths include needs assessment, program development and management, organization management and excellent communication and facilitation skills, with the ability to translate complex processes into digestible objectives. Excellent training and facilitation skills.

Developed the PCT Training Program from the ground up to prepare them for FDA reviews and integrated GMP and safety requirements into the skills training program for the Novartis Suffern site. Instituted certification examinations for the Novartis site, as well. Developed training tracking systems to assure that personnel were retrained/recertified within appropriate timeframes.

PROFESSIONAL EXPERIENCE OVERVIEW

Fair-Rite Products Corp, Wallkill, NY

Managed the Corporate Safety and Health Program, including safety, training and occupational health, providing process safety input on work operations and equipment. Managed most day-to-day activities related to safety and health, and assisted with the environmental program.

PCT, A Caladrius Company, Allendale, NJ

Developed and Managed the PCT EHS Program for a two-site biopharmaceutical operation processing and storing stem cell products, as a contract production facility. Formalized the EHS Program and developed all of the requisite training programs. Responsible for medical waste, hazardous waste, air permitting and occupational health programs, as well as Safety and Industrial Hygiene.

Progenitor Cell Therapy, LLC, Allendale, NJ

Developed and implemented a GMP and Technical Training Program (based upon Excel as the documentation, tracking and reporting database) and designing the baseline for a Corporate Safety Program. Developed and implemented a Training Tracking Program and establishing training curricula for each working position necessary.

TEVA/Barr Labs/PLIVA, Montvale, NJ

Associate Director, Health, Safety and Environmental

Managed all aspects of the Health and Safety Program (OSHA Compliance, Program Development, Accident Investigation, Process Safety) and most of the Environmental (RCRA, DoT, Solid, Medical Wastes, Stormwater, Contingency Plans) for two pharmaceutical sites.

PLIVA Pharmaceuticals, East Hanover, NJ (1 1/2 years)

Associate Director, Training Strategies

Developed and expanded Safety and Health, cGMP and Technical Operations Training Programs for the US segment of PLIVA. Evaluated present and future personnel training needs and provided technical and cGMP training support. (PLIVA was purchased by Barr Labs.)

Initiated a cross-skills training plan for the Company to improve workforce effectiveness, FDA compliance and company profitability

Set up a site skill certification program in response to FDA recommendations

Established a standard laboratory equipment training program for the QC laboratory to assure consistency of results.

Wyeth Pharmaceuticals, Pearl River, NY

Manager, Vaccines Technical Training

Established training needs and developed training programs and requirements for the Aseptic Vaccines Operation, relating to both cGMP and Technical Training for all phases of the process. Supervised a team of ten Technical Trainers supporting the various manufacturing phases in a rigorous regulatory environment.

Brought a major Aseptic Training Program to fruition for all clean room workers, to support quality improvement and increase business profitability for a critical vaccine product system

Novartis Pharmaceuticals, Suffern, NY (over 9 years)

Manager, Technical Training/Senior Technical Trainer

Established FDA-compliant training specifications for all operational positions, designed training programs and certified the effective completion of the training by the individual operators

Developed a curricula-based training effort and certification program (testing) to help assure compliance with FDA training requirements

Integrated production scheduling into the training requirements matrix, resulting in a first-year savings of $500M, in the cross-skills training program

Performed risk analyses for all major production systems for the new facility, minimizing loss potential and supporting system availability criteria

Orange and Rockland Utilities, Spring Valley, NY

Corporate Manager, Safety and Health

Directed the Safety and Health Program for a 1600 person operation, including six field work centers, two large Power Plants and laboratories, several hydro facility, gas propane lift stations and two Jet Power Units. Maintained existing programs and implemented new OSHA Programs that surfaced. Lead support through significant OSHA inspections and queries. Provided training for Safety and Health, and Environmental requirements.

EDUCATIONAL BACKGROUND

Masters, Industrial Engineering (Safety Engineering), Texas A&M University, College Station, TX

BS, Chemical Engineering, Clarkson College of Technology (now, Clarkson University), Potsdam, NY

PROFESSIONAL AFFILIATIONS AND CREDENTIALS

Certified Safety Professional (Comprehensive Level) - Retired

Certified Hazard Control Manager (Masters Level) - Retired

Licensed Professional Safety Engineer - Retired

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