Quality Assurance Engineer

JOHN P. SHELDON

727-***-**** nqfgls@r.postjobfree.com

EDUCATION

Masters of Business Administration, GPA 3.98

University of Phoenix – Tampa campus

Bachelor of Science in Chemical Engineering

The University of Nebraska-Lincoln, Lincoln, Nebraska

PROFILE

• Plant and Engineering Management, P&L, Operations Management, team leadership

• Process/Production/Project Engineering

• Project and Maintenance Management

• Cost center budgeting, CER preparation

• Environmental Compliance and Permitting

• Distillations, PFD’s & P&ID’s

• Optimization, monomers, polymers, fine chemicals, liquid products

• IQ, OQ, PQ and validation qualifications

• Master Production Scheduling (MPS)

• Microsoft Access, TurboCad

• Microsoft Word, Excel, Project Manager

• Pharmaceuticals, solid dosage, liquids

• Foods, Nutritional products, vitamins

• Chemicals & Consumer products

• Medical Devices, Packaging equipment

• cGMP, 21 CFR 210, 211, 820 and ISO 13485 and 510(k) filing experience

• Sterile and Non-sterile filling equipment

• Batch, extrusion and continuous operations

• FDA electronic OTC drug registration

• FDA electronic facility registration

• Materials Requirement Planning (MRP)

• Allen Bradley PLC/SLC 500 systems

• Lean manufacturing, TQM

PROFESSIONAL EXPERIENCE

Health-Tech, Inc., Boynton Beach, FL 2009 to present

Pharmaceutical / Cosmetics manufacturer with international sales.

Operations

• Responsible for Operations, R&D, Quality Assurance, cGMP and Regulatory functions.

• Filed for and received FDA registration for OTC pharmaceuticals.

• Responsible for 4 direct and 35 indirect employees.

• Completed formulation of 9 new products including batch records and submission of the OTC products for registration with the FDA and the State of Florida.

• Responsible for the startup of new products including all functions from Design and development planning through shipping.

• Provide scheduling for day to day operations and guidance on purchasing, cost center accounting and control.

• JIT and lean manufacturing techniques and statistical process control techniques initiated and reviewed

• Reviewed for selection MRP / MPS system (MISys) for Quick books application.

• Redesigned the warehouse increasing capacity by 40%.

• Initiated new SOP’s to upgrade facility to FDA requirements under 21 CFR 210, 211 and 820.

JOHN P. SHELDON PAGE TWO

BioTec Films, Tampa, FL. 2004 to 2008

Consumer/Pharmaceutical water soluble edible thin film manufacturer with international sales.

Operations Director

• Directed evaluation and refocusing of operations and programs to meet FDA and cGMP guidelines.

• Directed plant teams in cGMP and safety training modules to stay within OSHA rules.

• Responsible for 7 direct and 55 indirect employees.

• Provide guidance to Research & Development assuring production operations and personnel worked efficiently. Experience with batch reactors, drying ovens, HVAC and boilers.

• Lead technical operations staff in increasing production output and efficiencies up to 25% utilizing JIT and lean manufacturing techniques and statistical process control techniques

• Cost center, facility, P&L, and operations budgeting reducing costs by 10%.

Plant & Engineering Manager

• Directed and evaluated costing data for three successful launch products.

• Provide advice and consent to senior management on a variety of issues including cGMP, FDA, OSHA, safety and other various rules and regulations. Act as liaison between R&D and production operations for transfer of products including timelines, equipment, processes and procedures. Assured launch on time and under budget for several products.

Engineering Manager

• Evaluation of project and program scopes for engineering projects relating to operations, maintenance and facility, improving overall production operations by 10%.

• Manage engineering and operations budgeting process for facility.

• Manage the maintenance and facilities personnel and assign program tasks reducing downtime by 10%.

• Chaired safety programs for plant.

Halkey-Roberts Corporation, St. Petersburg, FL 2001 to 2004

Medical Device Manufacturer with national sales.

Senior Design Transfer Engineer / Coordinator

• Directed writing of qualification protocols for new products, processes and equipment. Initiated production start up operations. Managed liaison operations between R&D engineering, quality assurance, regulatory and production assuring the launch of 3 new medical device products.

• Evaluation and transitioning of medical components and devices from engineering to the plant floor ensuring a smooth transition with reduced downtime by 5%.

• Writing Quality Assurance and Standard Operating Procedures and protocols for new and existing products to meet FDA guidelines. Prepared, submitted and had approved an FDA medical device 510(k).

• Initiated start up of new operations on plant floor and directed production team members integrating statistical evaluation of processes and JIT into the production technology. Experience with automated and rotating equipment, blow molding and mixing equipment.

• Supervised Document Control Clerk.

Bausch & Lomb Pharmaceuticals, Tampa, FL 1999 to 2000

Ophthalmic pharmaceutical manufacturer with international sales.

Senior Project/Process Engineer

Project management responsibilities for the Envision TD project.

• Identified and evaluated all project needs for the construction of the Envision suite.

• Experience with facilities construction, contracts and vendor specifications.

• Management of the general contractor and budget of $1.6 million for the project.

• Development of all capital appropriations requests and specifications for project.

JOHN P. SHELDON PAGE THREE

ADDITIONAL PROFESSIONAL EXPERIENCE

R. P. Scherer NA (Cardinal Health), St. Petersburg, FL

Pharmaceutical, Over the Counter (OTC) and nutritional product producer of gel caps.

Project/Process Engineer

Project management responsibilities for building and equipment requirements for gel cap production.

• Identification and evaluation of project scopes and plant layouts with Project Management.

• Equipment selection, budget development, equipment installation & start up.

• Experience with pan coaters, batch reactors, drying equipment, HVAC, Steam utilization, mixing equipment, and gel cap presses.

• Capital appropriation request development up to $2.5 million.

• Plant and production support in the manufacture of pharmaceutical and nutritional gel caps.

• Packaging, mixing and blending equipment.

Amway Corporation, Ada, MI

Consumer products manufacturer to a private distributor network.

Senior Chemical Process Engineer

Plant engineer supporting the Liquid Manufacturing facility for all process, production and project related requirements for the successful operation of this plant. Experience with liquid, cream, and suspension mixing, pumps and piping, high speed liquid and semi-solid filling and packaging equipment and conveyor and palletizer equipment. Palletizer project resulted in a 21% ROI and 1.8 year payback.

SmithKline Beecham, Lincoln, NE,

Supervisor, Pharmaceutical Compounding (mixing & blending) /Tableting Operations.

Directed shift staff of 23 employees.

Company provided animal biologics and pharmaceutical products. Experience with fluid bed dryers / coaters, ribbon and axial mixing equipment, tableting equipment, creams, suspensions, solid and liquid dosage materials. Researched and verified a 17% reduction in process utilization batch timing with the purchase of automated lift trucks.

PROFESSIONAL AFFILIATIONS

American Institute of Chemical Engineers

American Society of Mechanical Engineers

International Society of Pharmaceutical Engineers

National Registry of Food Safety Professionals – Certificate for Food Safety Manager

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