SUMMARY:

• Seasoned manager with extensive experience in production operations, product and process development, pilot lab operations, process and project engineering, quality assurance and regulatory affairs in the pharmaceutical, medical device, chemical, food and consumer product industries.
• Decisive skills developed through line and staff roles in a wide variety of functional areas.
• Dynamic leader with a proven track record of increasing company value through systematic review and improvement as a change specialist who has effectively led divergent groups to increase sales, reduce costs and increase productivity through team leadership.
• Process/Production/Project Engineering
• Operations and Engineering Management, team leadership, Regulatory Analysis
• IQ, OQ, PQ and validation qualifications
• Lean Manufacturing, JIT, TQM
• Path Wise CAPA Root Cause Analysis
• Taguchi Design Methodology
• Ishikawa, FMEA Process Analysis
• Optimizations, monomers, polymers, fine chemicals, liquid and solid products
• Cost center budgeting, CAR preparation
• Microsoft Access, TurboCad, Documentum
• 510(k) preparation and submission
• OTC Pharmaceuticals, Medical Devices
• Electronic Facility, OTC pharmaceuticals and medical device registration, Kintana
• Master Production Scheduling (MPS)
• Materials Requirement Planning (MRP)
• Blending, mixing & compression operations, liquid formulation and mixing
• Pharmaceutical product formulations
• Sterile and Non - sterile manufacturing
• Batch and continuous operations
• Microsoft Word, Excel, Project Manager

PROFESSIONAL EXPERIENCE:

Confidential, Tampa, FL

Contract Packaging Engineer

Responsibilities:

• Provide engineering support for the design and development of new innovative packaging systems for existing products and R&D Pipeline products.
• Serve as the package development technical team member on cross functional global teams defining component testing and optimization, manufacturing process development and insuring regulatory and quality compliance within industry standards (FDA, ISO, etc.).
• Functional user of Documentum and Kintana software.

Confidential

Project Engineer

Responsibilities:

• Provided engineering project management for planning, design, development, testing, validation and documentation of components and finished cardiac medical devices.
• Familiar with Fourth Shift software.

Confidential, Florida

Senior Quality Engineer

Responsibilities:

• Provided quality review of medical device manufacturing documents for conformance and release to distribution.
• Wrote quality SOP’s and work instructions for manufacturing processes.
• Communicate effectively within team, to R&D and Engineering management on packaging development progress.

Confidential

Process/Quality Engineer

Responsibilities:

• Provided process and quality review of manufacturing processes for regulatory conformance.
• Provided CAPA (corrective action preventive action) investigation reporting on internal and external deviation reports for medical device company that manufactures blood reagents for patient diagnostic testing.
• Functional user of Trackwise software.
• Path Wise CAPA Training for root cause analysis.

Confidential, Boynton Beach, FL

VP of Operations

Responsibilities:

• Directed Operations, Quality Assurance, Regulatory, Engineering, Production, Human Resources, Supply Chain and R&D departments.
• Filed for and received FDA registration for nine new OTC pharmaceuticals (hand sanitizers and tooth pain gel) and one medical device, (Mouthguard, antibruxism device) coordinated registration activities with 21 CFR 210, 211, 820 and ISO 9001 and 13485.
• Directed 4 managers and 35 indirect employees for daily activities.
• Formulated & electronically registered 2 new products (one OTC, one Cosmetic) increasing sales by $4.05 million in second half of fiscal year 2009. Set up MISys MRP software.
• Provided guidance to operations on scheduling, purchasing, cost center accounting and control.
• Worked with company owners to produce budget requirements for operation activities.
• Conducted employee performance reviews for wage and promotion activity and handled employee discipline procedures per company policy.

Confidential, Tampa, FL

Director of Operation, Plant & Engineering Manager

Responsibilities:

• Directed operations, quality assurance, regulatory and production/warehousing.
• Promoted from Engineering Manager to Plant Manager and then to Operations Manager.
• Directed 7 supervisors and 55 indirect employees.
• Provided guidance to Research & Development assuring production operations and personnel worked efficiently. Experience with batch reactors, drying ovens, HVAC and boilers.
• Controlled cost center, facility, P&L, and operations budgeting reducing costs by 10%.
• Provided engineering changes that increased throughput of product increasing sales by $1.995 million per year. Utilized SAP ERP systems.
• Managed the maintenance and facilities personnel and assigned program tasks reducing downtime by 10%. Directed the predictive / preventative maintenance program and Chaired safety programs.

Confidential, St. Petersburg, FL

Senior Design Transfer Engineer / QA Coordinator

Responsibilities:

• 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.
• A medical device valve, (the Robertsite valve) used in IV sets
• All purpose plastic component valve used in catheter sets.
• All valves were comprised of injection molded components that were assembled on automated equipment at plant site.
• Evaluated and transitioned industrial injection molded plastic valve and medical components / devices from engineering to production ensuring a smooth transition with reduced downtime
• Wrote SOP’s for assembly of injection molded parts for industrial products.
• Completed writing Quality Assurance and Standard Operating Procedures and protocols for new and existing products. Prepared, submitted and had approved an FDA medical device 510(k).
• Directed Document Control Clerk to assure training programs and SOP’s were completed.

Confidential, Tampa, FL

Senior Project/Process Engineer

Responsibilities:

• Identified and evaluated all project needs for the construction of the Envision suite.
• Identification and evaluation of all equipment requirements for the Envision project.
• Management of the general contractor and budget of $1.6 million for the project.
• Development of all capital appropriations requests and specifications for project.
• Experience with facilities construction, contracts and vendor specifications.