Contract position: World's leading provider of injectable drugs has an immediate need in Andover MA for a Validation Engineer to provide validation support for the execution of IOPQs and RQs to enhance or sustain critical process equipment. This is a contract position expected to last 12 months, could be longer based on performance, possible temp to perm. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now! Responsibilities for the Validation Engineer
Requirements for the Validation Engineer
- Performs all work in compliance with cGMPs, Quality, and Safely according to site requirements
- Own and execute equipment commissioning and qualification activities
- Create and execute test plan according to an approve implementation plan from Quality Tracking System (QTS)
- Initiate, execute, track Change Controls as needed per laboratory requirements.
- Performs and documents instrument requalification, calibration and performance verification after the move according to approved procedures
- Prepare laboratory reagents for use in instrument performance verification/calibration testing
- Manage the qualification effort i.e. coordination of materials and equipment
- BS in Engineering, Chemistry or Biology
- 8+ years of IQ/OQ/PQ experience, preferably in the pharmaceutical or biopharmaceutical GMP industry.
- GMP experience is a must
- GMP Aseptic experience
- Drafting protocols or change controls is a plus
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.