Shannon Warren

About Shannon Warren

Over 7 years of experience as a Validation Engineer in Pharmaceutical and Biomedical Companies with wide ranging proficiency in Computer System Validation(CSV), Equipment and process validation as per FDA and GAMP 5 regulations.• Well versed in validating computer systems by writing Standard Operating Procedures (SOPs), Validation Master Plan (VMP), Installation Qualifications (IQs) and Validation Summary Report (VSR).• Good Understanding of 21 CFR part (11, 50, 56, 210, 211, 820) and other FDA rules and Regulations.

Experience

1. Validation Engineer

   Stryker

   Dec 2015 — Present · NJ, US

   Interacted with end users to understand business processes and gather requirements• Created User Requirement Specification and Functional Requirement Specification documents• Validated computer system interface with laboratory instruments such as Spectrophotometer, GC and HPLC.• Involved in generation and execution of process validation protocols for oral solid dosage forms.• Developed site validation plan by supporting serialization project implementation on packaging lines.• Worked in a strictly regulated cGXP environment for all the aspects of Computer Systems and Equipment Validation.• Developed and maintained IQ, OQ, PQ protocols for equipments like HPLC, GC, MS, Autoclaves, Freezers, Refrigerators, and other analytical laboratory equipment.• Developed Standard Operating Procedures (SOPs)• Coordinated with the quality assurance team in updating and maintaining the SOPs for laboratory equipment.• Performed troubleshooting, data analysis and acted as a regulatory liaison.• Maintained the Requirement Traceability Matrix (RTM).• Conducted User Acceptability testing and documented the User Acceptance Test Summary Reports (TSR).• Contributed towards development of Validation Summary Report (VSR). • Actively participated in project meetings and discussions

Education

• University of Houston-Clear Lake

  Bachelor's degree, Chemistry

  2004 — 2009