Luke Stark

Luke.Stark@gmail.com

 

Quality Engineer

Quality Auditing / Quality Engineering / Quality Systems

 

I am a quality assurance engineer who has eight years of experience working in the life sciences industry. I possess extensive knowledge of medical device manufacturing and pharmaceutical manufacturing quality assurance processes particularly FDA regulatory requirements 21 CRF Part 211 and 11.

 

Expertise 

  •  Quality Auditing
  • Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams)
  •  Systems Design & Automation
  • Good Automated Manufacturing Practices (GAMP5)
  • Regulatory Expertise (21 CFR Part 211, 21 CFR Part 11)
  • Familiarity with 21 CFR Part 820, ISO13485
  •  Implement/create procedures to meet regulatory/ISO requirements

 Professional Experience

                    

Performance Validation – Indianapolis, IN

Life Science Consultants for regulatory and GMP Manufacturing

Senior Validation Engineer, 2005 to Present

Project Leader

Create pharmaceutical and medical device manufacturing periodic quality reviews/audits, and system validation documentation including: system manuals, system overviews, PLC system designs, system testing (installation, operational, and performance), user requirements, requirement/testing traceability, document tracking, and general project management.

Quality Initiatives and Results:

 


Education & Credentials

 

Rose-Hulman Institute of Technology – Terre Haute, IN

Bachelor of Science in Computer Engineering, 2/2006

 

Professional Qualification Statement

Overview

Luke has experience supporting cGMP compliance projects for pharmaceutical and medical device manufacturers since 2005.  He has experience in the development and execution of validation documentation for computer systems and process equipment including the associated control system.  He also has experience in creating quality reviews (periodic quality evaluations/periodic reviews) and auditing.

Project Responsibilities

Systems and equipment experience

Certification

Project Experience

Quality and Validation Consulting (Milwaukee, Wisconsin)

July 2011, August 2011, October 2011 through February 2012, Aug 2012 through March 2013, October 2013-December 2013 – Project Lead and Consultant

Lead the development, implementation and training of a best practices approach for the qualification and validation of pharmaceutical manufacturing equipment qualification and validation. This work included the development of a compliant and less burdensome qualification and validation program.


Manufacturing DeltaV Upgrade Validation Consulting (Indianapolis, Indiana)

April 2012 through December 2013 – Validation Team Member

Provided validation support and consulting to a system during DeltaV system upgrades. This included review of all SOPs and actions taken on the equipment in the field against the changes made in the DeltaV upgrade to provide a risk based testing solution to ensure equipment compliance and client peace of mind.

 

Computer System Validation Consulting (Indianapolis, Indiana)

June 2011 through March 2012 – CSV Team Member

Created computer system validation plan, change control process, review of computer system documentation against client requirements, GAMP, and Part 11 requirements for a client document control system used in GMP activities.

 

Support for New Manufacturing Location (Indianapolis, Indiana)

August 2010 to January 2012 – Team Member

Team member, responsible for the development and execution of qualification and validation protocols for manufacturing equipment. Developed standard operating procedures required to meet GMP compliance. This work was subject to FDA review and found compliant during the client PAI inspection.

 

Quality Review of Pharmaceutical Equipment (Waukegan, Illinois)

May 2010 to June 2010 – Project Lead and Team Member

Lead the development and implementation of a comprehensive quality review system used to perform the semi-annual and annual quality reviews of pharmaceutical manufacturing equipment.    Executed quality reviews of pharmaceutical manufacturing equipment—including researching, analyzing, and presenting data relevant for semi-annual and annual reviews.

 

Support for Manufacturing Performance Monitoring System (Indianapolis, Indiana)

March 2010 to August 2010 – Team Member

Provided Allen-Bradley Logix5000 (ladder logic) and FactoryTalk View Studio (HMI screens and settings) source code reviews, design document development, qualification document development, and qualification execution.

 

Quality Review of Pharmaceutical Equipment (Indianapolis, Indiana)

January 2009 to August 2010, January 2012 to April 2012 – Team Member and Project Lead

Provided project management for multiple quality reviews.  And as a team member was responsible for researching, analyzing, and presenting data relevant for semi-annual and annual quality reviews of various pharmaceutical manufacturing equipment.

 

Temperature Mapping of Pharmaceutical Equipment (Indianapolis, Indiana)

March 2008 to December 2008 – Team Member

Team member responsible for development of qualification packages for refrigeration and incubation equipment.  Provided support for document and equipment control.  Executed temperature mapping protocols using Kaye Validator 2000 and Veriteq equipment.

 

Quality Review of Pharmaceutical Equipment (Indianapolis, Indiana)

June 2007 to December 2007 – Team Member

Team member responsible for researching, analyzing, and presenting data relevant for semi-annual and annual quality reviews of various pharmaceutical manufacturing equipment.

 

Cartridge Recovery System Qualification (Indianapolis, Indiana)

Oct. 2007 to December 2007 – Team Member

Team member responsible for the development of validation package and execution of qualification protocols for a parenteral cartridge recovery system.

Purified Water Control System and Qualification (Indianapolis, Indiana)

May 2007 to June 2007 – Team Member

Team member responsible for the development of computer system validation of the control system for a building-wide purified water system including development of system design specification from provided ladder logic (AB Control Logix).

 

Environmental Monitoring Equipment (Indianapolis, Indiana)

February 2007 to May 2007 – Team Member

Team member responsible for the development of qualification packages for multiple types of environmental monitoring equipment and execution of the equipment testing.

 

Packaging Line Addition of an Automated System (Indianapolis, Indiana)

January 2006 to October 2006 – Team Member

Team member responsible for development of the qualification package for a customized assembly machine including: test plan, user requirements, factory acceptance commissioning, installation qualification, operational qualification, performance qualification, and support documentation.  Also support qualification of a line speed increase and the installation of new part feeders.

 

Manufacturing Process Addition of Equipment Qualification (Indianapolis, Indiana)

August 2006 to October 2006 – Team Member

Team member supporting the requalification of granulation and fluid bed dryer equipment, including control system changes.

 

Compressed Air Filter Re-Qualification (Indianapolis, Indiana)

November 2005 to December 2005 – Team Member

Team member responsible for development and modification of protocols for filter qualification in a compressed air system.

 

High Pressure Wash for Operations PQE (Indianapolis, Indiana)

October 2005 to December 2005 – Team Member

Team member responsible for preparation of a periodic quality evaluation for the high-pressure wash for operations system.

 

Laboratory Nitrogen System PQE (Indianapolis, Indiana)

August 2005 to October 2005 – Team Member

Team member responsible for preparation of a periodic quality evaluation for a direct impact nitrogen system.

 

Dry Products (Indianapolis, Indiana)

August 2005 to September 2005 – Team Member

Team member responsible for cataloguing and implementing an alternate labeling system for existing validation documentation.

 

July 2005 to August 2005 – Team Member

Team member responsible for qualification activities including drawing verification for HVAC systems