Validation Engineer I

Canton, MA

Job ID: 682

Job Req code: 682

Category: Quality Systems

Job Type: Quality Systems

The Validation Engineer I/II will be designated to support validations for a CGMP facility. The engineer will be responsible for assisting with executing Installation, Operation, Performance Qualification, Requalification and Revalidation protocols for manufacturing equipment, clean rooms, utilities and systems using established validation templates, standards and procedures. The Engineer will write and execute protocols for assigned validations. The engineer will also assist in process and cleaning validations.

Job Responsibilities:
• Prepares protocols and reports for validation, requalification and revalidation work
• Assists with coordination and execution of 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
• Prepares, reviews and summarizes equipment history files to assess the validated state of equipment
• Assist in process and cleaning validations as required.
• Supports other Validation Engineer II/III in the execution of validation protocols.
• Participate in the 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/Bachelor's degree with 1-3 years of experience in validating GMP systems.  Candidate will be a highly motivated and creative individual with  hands on validation skills working under minimal supervision.  A solid level of competency with Kaye Validator programming and calibration of thermocouples, validation of test equipment, and technical writing skills are preferred. Strong familiarity with Microsoft Office, Word, Excel, and PowerPoint is required.