BRUCE NEAGLE

http://www.linkedin.com/pub/*/***/**b

http://www.linkedin.com/pub/6/873/76b

**** **** ******,

Windsor, Ontario

N9C-1P4

E-mail: ac2e0o@r.postjobfree.com

Phone: 1-226-***-****

CAREER OBJECTIVE

Seeking a senior position in the Pharmaceutical, Biotechnology, Nutraceutical, Cosmeceutical, Animal Health, or Food Industries.

PROFESSIONAL CAREER SUMMARY

I am a hard-working self-starter professional Scientist/Engineer with several years experience in various regulated industries.

Power Statement: Cleaning Validation Overview- I am a versatile professional with more than 25 years of technical experience Quality Control (Microbiology and Analytical Chemistry), Manufacturing, Quality Assurance and Validation Engineering, in FDA regulated manufacturing, bringing several years hands-on experience with equipment validation, process validation, and cleaning validations. My experience includes CIP, COP (manual) of injectable and oral administered pharmaceuticals of the cleaned equipment including a Fette tablet press, and established clean hold times. I have participated in the cleaning of large soft gelatin plant. I have managed the start-up and qualification of successful OTC cleaning validation plan and execution. I have excellent organizational and time management skills, Strong decision-making and creative problem solving skills and the ability to develop, organize, and manage multiple tasks. My responsibilities have included preparing validation master plans, protocols, and executing qualification activities for plant equipment, facilities, utilities, process control systems, computer systems, and cleaning and process validation projects for his clients and the writing of final reports. I have reviewed The ISPE’s new guide on ‘cleaning validation’ and the FDA’s new guidance ‘Analytical Procedures and Methods: Validation for Drugs and Biologics’. I am very knowledgeable with current regulation and guidelines of CFR and ISO requirements. I have qualified manual and automated cleaning processes, verified sequence of operations for CIP and SIP systems and qualified COP and parts washers.

EMPLOYMENT HISTORY

Pharmaceutical Services Corporation 2015-Present

TECHNICAL WRITER

Wrote several protocols and reports for clients

Oxford Global Resources 2013-2013

CLEANING VALIDATION SPECIALIST

Wrote Cleaning Validation Cover Sheets assessing the current status of a CIP system.

Evaluated manual cleaning procedure and wrote SOP/procedure.

Wrote a Performance Qualification for a Parts Washer.

Oxford Global Resources 2012-2013

CLEANING VALIDATION SPECIALIST

Wrote a Site Cleaning Master Validation Plan (SCVMP) and Cleaning Verification Protocol.

Wrote Cleaning Validation Cover Sheets assessing the current status of a CIP system.

Wrote a Performance Qualification of both Analytical and Microbiological Dishwashers.

Validant Strategic Consulting 2012-2012

VALIDATION COMPLIANCE TEAM LEAD

As part of site remediation at Novartis Lincoln authored several cleaning validation protocols (and executed), reports, CPATs, and other supporting documentation as required by GMP requirements. Wrote and reviewed both cleaning and process validation protocols for oral non-sterile tablets and powders (Excedrin and Sentinel). Reviewed and commented on a Site Cleaning Master Validation Plan (SCVMP).

PharmEng Validation Consultants 2011-2012

VALIDATION CONSULTANT

As part of site remediation plan authored several articles, SOP’s, protocols, and final reports. Wrote cleaning validation protocols for parenteral generics at Ben Venue.

Validation Success, Windsor, Ontario 2008-2010

SENIOR VALIDATION CONSULTANT (Subject Matter Expert)

Validation Consultant and major contributor to a website, which is dedicated to the validation of drug products, therapies, and medical devices. Wrote validation protocols and reports for clients.

Gelcell Encapsulation Incorporated, Windsor, Ontario 2007-2008

VALIDATION SPECIALIST

Member of strike team who obtained FDA approval to manufacture a soft gelatin generic drug product Dronabinol.

Developed and Validated HPLC Test Methods for active pharmaceutical ingredients, related substances, and cleaning agents.

Wrote and reviewed Standard Operating Procedures.

Conducted Laboratory Out of Specification Investigations.

Wrote and reviewed technical documents including Master Validation Plan, Method Validation, Cleaning Validation, Process Validation Protocols and Reports including a Drug Development Report (as a QbD initiative for a generic).

Wrote, reviewed and executed Cleaning Validation protocols, and final reports.

King Pharmaceuticals Incorporated, Rochester, Michigan (Parenteral Facility) 2001-2006

SENIOR ANALYTICAL DEVELOPMENT SCIENTIST

Developed impurity and degradant profiling and identification in hormones and anti-viral drugs using chemical and physical methods.

Completed several residual analyses by HPLC and FTIR.

Accomplished method development and validation for several drug substances, drug products, and related compounds.

Reformulated drug products based on stability data.

Wrote, reviewed and executed Cleaning Validation protocols.

Performed Process Validation of Lyophilizers and Smeja Vial Stopper Siliconizer.

Member of a strike team responsible for the technical transfer of a barbiturate drug product.

Set impurity specifications in drug product using long term stability data

Internet Consultants International Ltd., Royal Oak, Michigan 2000-2001

INTERNET CONSULTANT/PART-OWNER

Designed and developed websites utilizing internet marketing strategies and databases.

Performed client services including web site activity and security monitoring.

Accucaps Industries, Windsor, Ontario 1995 - 1999

QUALITY CONTROL MANAGER

Managed quality control in a soft gelatin encapsulation process, manufacturing products for pharmaceuticals, dietary supplements, and cosmetics industry.

Managed a staff of over 20 professionals and technicians.

Wrote, reviewed, and approved Cleaning Validation protocols and reports.

Responsibilities also included staff selector, staff development, budgets, procurement, coordination with other departments, and addressing customer quality concerns.

Managed the growth of the Quality Control Department through various stages to achieve cGMP compliance and Lab Safety.

System Administrator who was responsible for the computer validation of the Millennium HPLC system software.

Completed validation of an inline TOC used to monitor the facilities process water.

Business development of Clinical Lots

Seaway Analytical Laboratory, Kingston, Ontario 1990 - 1994

QUALITY ASSURANCE SPECIALIST

Administered quality assurance in a small pharmaceutical/environmental contract laboratory. Duties included equipment maintenance, data base management, training, bench work, and ensuring the smooth operation of the business.

Business development and marketing for GC analytical services.

Agri-Service/ENTECH Laboratory, Kitchener, Ontario 1985 - 1990

LAB MANAGER/PART-OWNER

Managed the operation of a diversified, contract laboratory providing analytical services for agriculture, environmental, food, and pharmaceutical industries.

Part owner and director of business, contributing technical and management skills to the successful operations including method development.

Casco Inc., Cardinal, Ontario 1979 - 1985

LAB COORDINATOR/LAB FOREMAN

Supervised the daily operations of an analytical laboratory for a food manufacturer specializing in high fructose corn syrup, glucose, starch, and corn oil.

Part of a project team that set up a carbohydrate laboratory at the Port Colbourne site near Welland, Ontario.

Set up and maintained a process NIR to do starch, oil, protein, fiber analyses in feed.

EDUCATION & TRAINING

Bachelor of Science (Biology and Chemistry), University of Waterloo

Contact this candidate