Medical Device System

AREAS OF EXPERTISE

• Cleaning Validation

• Over 20 years of Technical Engineering experience in programming and operating large scale equipment in a cGMP

Manufacturing Facility

• Protocol Development and Execution; Business Writing

• IQ/OQ/PQ and Audits

• Risk Assessment and Quality Investigations

PRODUCTION EQUIPMENT EXPERIENCE

• Parts Washers

-- Girton, MORK and Sani-Matic

• Filling Lines

-- TL/BOSCH

• Vial Washing Systems

-- IMA, LIBRA and Genesis

• CIP Tank Cleaning Skids

• Lyophilizers [Freeze Driers]

-- Stokes and Hull

• Terminal Sterilizers

-- Barriquand and ETC

• Autoclaves

-- ICOS and ETC

• Hot Air Ovens

-- ICOS and Gruenberg

• Automatic Check Weigher

• Stopper Washers

-- ICOS and Huber

• Automated Packaging Units

-- Dividella, McBrady Exterior Vial Rinser and ICORE Check Weigh

• Temperature Monitoring System

-- Kaye Digistrip

COMPUTER SKILLS

• Microsoft Office

-- Word

-- Excel

-- PowerPoint

-- Outlook Express

• IDEA for CON (SOP database)

• Trackwise (Deviation Logging System)

• Oracle

• AMMS (Advanced Maintenance Management System)

• Learning One Source

• Shawn L. Phillips

3878 Oneida St.

Stow, Ohio 44224

330-***-****

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

OBJECTIVE

I am seeking a full-time, permanent position. My qualifications allow me to work in many areas of the workplace.

QUALIFICATIONS

• Managed and operated numerous Recipe Interactive Programs with HMI screens to set Validation Critical Process Parameters.

• Programmed and operated Hot Air Ovens, Lyophilizers, Autoclaves, Barriquand Terminal Sterilizers and Stopper Washers.

• Established cost savings in various departments by implementing shorter cycle times using less water and cleaning agents with the same

effectiveness.

• Performed Freeze Drier Cleaning Validation Studies using the Lyophilization and CIP System.

• Medical device experience in the Regulatory Compliance Field.

• Performed validation functions, IQ/OQ/PQ and routine audits on Vial Washing Systems.

• Conducted an International Factory Acceptance Test (FAT) for a Packaging System and performed validation functions using the Vision

System.

• Coordinated and performed equipment cleaning validation studies; including Surface Area Calculations, Rinse and Swab Sampling, and

Microbiological Sampling, in conjunction with other departments to achieve aggressive timelines.

• Managed the company’s cleaning agent changeover by developing protocols; leading project delegation, execution and coordination with outside

departments; and revising SOPs.

• Performed validation activities on tray washers from IQ, cycle development, cleaning agent changeover and yearly performance audits.

• Performed full IQ/OQ/PQ for an Ethanol Transportation System, a Vapor Compression Distillation Unit, and Vial Washing Systems.

• Supervised and trained over 70 employees and contractors.

• Managed studies for Cleaning Validation Sampling Groups.

• Performed Manufacturing Validation, Container Closure Integrity and Bulk Hold Studies.

• Certified in Computer System Validation Training.

• Certified in Filtration and Integrity Testing of Sterilizing Grade Filters.

• Well organized with good communication skills; flexible and able to embrace change; able to manage multiple duties and tasks; strong

ability to work under pressure and meet time constraints.

• Excellent technical writing and analytical skills.

• Strong interpersonal and leadership skills.

EDUCATION

BS in Electrical Engineering Technology

Minor in Mathematics and Computer Programming

Youngstown State University

Furthered education with Upper Level Engineering Courses

Youngstown State University and University of Akron

EMPLOYMENT HISTORY

AEROTEK ENGINEERING @ INVACARE CORPORATION

November 2013 to present

Elyria, Ohio

BEN VENUE LABORATORIES

July 1992 to October 2013

Bedford, Ohio

Contact this candidate