Validation Engineer II/III

Norwood, MA

Job ID: 561

Job Req code: 561

Category: Quality Systems

Job Type: Quality Systems

The Validation Engineer II/III will be designated to support validations for a CGMP facility. The engineer will be responsible for developing and executing Installation, Operation, Performance Qualification, Requalification and Revalidation protocols for manufacturing equipment, clean rooms, utilities and systems using established validation standards and procedures. The Engineer will write and execute protocols and maintain records for validations. The engineer will also assist in process and cleaning validations.
 
Job Responsibilities:
  • Prepares protocols and reports for validation and revalidation work
  • Coordinates and executes validation studies for equipment including autoclaves, glass washers, depyrogenation ovens, utility systems (purified water, WFI water, gas systems, clean steam), incubators, clean rooms, freezers, and cold rooms 
  • Performs testing using standard concepts, practices and procedures of the CGMP process
  • Reviews and summarizes equipment history files to assess the validated state of equipment
  • Performs a variety of validation tasks and projects outside classical validation tasks and apply diverse engineering development skills in a creative manner in order to increase operational efficiencies and product quality, and decrease costs 
  • Assist in process and cleaning validations as required.
  • Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects

Requirements

The candidate must have previous validation experience in Pharmaceutical/Medical Device industry, be familiar with aseptic processing and clean room operations, be able to work independently, possess strong organizational skills, and have good written and verbal communication skills. Minimum Associates/Bachelors degree with 2-5 years experience validating GMP systems.  Candidate will be a highly motivated and creative individual with strong hands-on validation skills working under minimal supervision.  A high level of competency with Kaye Validator programming, validation of test equipment, and technical writing skills are preferred.