System One Services Validation Engineer in Springfield, Massachusetts
Validation EngineerSpringfield, MA
Responsibilities for Validation Engineer:
Oversee Manufacturing, Quality Control, Facilities, IT and Materials Management in the implementation of validation activities
Assist in preparing annual site Master Validation Plans and annual site Validation/Qualification reports
Develop, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance client and industry standards.
Assist with client and FDA audits by explaining validation and qualification activities performed at the site
Requirements for Validation Engineer:
3-5 year’s experience the pharma environment working with the validation and qualification of equipment, utilities, facilities and IT systems.
Strong background in GMP
Highly knowledgeable in the functional operation of equipment used in the production of active pharmaceutical ingredients
Ability to learn how equipment functions and then design appropriate validation/qualification protocols.
Knowledgeable in computer programs including Microsoft Word and Excel.