System One Services Validation Engineer in Springfield, Massachusetts

Validation EngineerSpringfield, MA

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Type:Direct-Hire

Category:Engineering

Job ID:117102

Date Posted:05/26/2017

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.

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