Training Safety

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

** ******* **** ****: 845-***-****

New Hampton, NY 10958 Cell: 914-***-****

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

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 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.

PROFESSIONAL EXPERIENCE

Fair-Rite Products Corp, Wallkill, NY (Consultant - Part Time) October 2016 – Present

Work was periodic over this timeframe, with the last two years continuous part time (limited by contract to below health care requirements). Continue development, implementation and management of the site EHS Program for the Wallkill site, and provide technical and administrative support for one remote site (Flat Rock, IL). Develop EHS training programs and provide related training. Provide technical guidance on the introduction of new chemicals and processes from an EHS safety engineering viewpoint. I also did contract work for PCT Hitachi (was Caladrius) during this same timeframe.

PCT, A Caladrius Company, Allendale, NJ (Consultant) July 2013 – August 2016

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 (Feb 2016-Aug2016) and developed all of the requisite training programs. (2016). Responsible for medical waste, hazardous waste, air permitting and occupational health programs, as well as Safety and Industrial Hygiene. Participated in the selection and orientation process of the permanent EHS Specialist.

Provided Operations and QA support in the form of Data Management, Ongoing Project Data Analysis and Trending, Compliant Training Program Development, Technical Training Program Development, Validation Data Verification and Report Closure, General Product and Process Development work (Jul 2013-Feb 2016). Supported the development of the QT9 Training Curricula and made recommendations for upgrading the overall system to better fit the needs of the organization.

Momentive Performance Materials R&D Center, Tarrytown, NY Jun 2011 – May 2013

Develop and manage the site EHS/Training Program for the R&D Center. Involved in all phases of the Safety, Health and Environmental Program to bring it into compliance with OSHA requirements. Responsible for EHS Training Requirements for the R&D Center.

Progenitor Cell Therapy, LLC, Allendale, NJ Oct 2009 – Aug 2010

Employed by Progenitor Cell Therapy, LLC to develop and implement a GMP and Technical Training Program, and designing the baseline for a Corporate Safety Program. Developing and implementing a Training Tracking Program and establishing training curricula for the positions.

TEVA/Barr Labs/PLIVA, Montvale, NJ 2007 – June 2009

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. Major programs included Lockout, Confined Space Entry, Hazard Communication, Laboratory Safety, Respiratory Protection, Spill Response and Emergency Response Planning.

Supported NJ ISRA projects, including mandatory site remediation critical to site closure authorization

Designed a Risk Analysis/Hazard Assessment Implementation Plan for the Corporation to eliminate/limit risk exposure for high hazard operations.

PLIVA Pharmaceuticals, East Hanover, NJ 2005 – 2007

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

Designed and Managed the site cGMP Training Program to maintain compliance with mandatory FDA training and education requirements

Managed the Site Safety Committee

Wyeth Pharmaceuticals, Pearl River, NY 2005

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 1995 – 2004

QA Project Manager (~3 years)

Facilitated the Global Harmonization of process flows relating to QA Quality Standards worldwide, which was critical to standardization of Quality Procedures throughout Novartis.

Managed the development of standardized Novartis Quality System Process Flow Diagrams for Global QA

Novartis Pharmaceuticals, Suffern, NY

Manager, Technical Training/Senior Technical Trainer (~4 years)

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 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

Novartis Pharmaceuticals, Suffern, NY

Safety Engineer (~2 years)

Provided technical support for production operations through the performance of safety reviews and risk analyses for a major state-of-the-art facility expansion.

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

Fair-Rite Products Corp., Wallkill, NY 1995

Safety Engineer (Consultant ~4 months)

Developed and implemented (including training) a Safety Program for the Wallkill site. Work done at the plant included a machine shop, tool manufacturing group, `40 presses of various sizes, several horizontal and vertical kilns (~2500 degrees F), Grinding, Burnishing, Inspection and Shipping. I also spearheaded the site team during an OSHA inspection of the facility.

Orange and Rockland Utilities, Spring Valley, NY 1987-1995

Corporate Manager, Safety and Health (7 1/2 years)

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 numerous OSHA inspections and queries, based on union concerns. Provided training for Safety and Health, and Environmental requirements. Worked with a significant number of hazardous chemicals including asbestos and PCBs in transformer equipment. Facilities were spread over three states, and I had a staff of normally eight personnel to support the Safety and Health Program.

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

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