Validation Engineer

1 month ago


Newark, United States IDR, Inc. Full time

IDR is seeking a Validation Engineer to join one of our top clients in Newark, CA. This position is a 100% onsite role and contract opportunity. If you are looking for an opportunity to join a large organization and work within an ever-growing team-oriented culture, please apply today


Position Overview/Responsibilities for Validation Engineer:

  • Ensure quality and compliance in accordance with established procedures and standards
  • Generate, review and approve base level document such as Validation Plan, URS, FRS, DS, and SOPs.
  • Generate, review/approve and executing computer validation (IQ, OQ, and PQ) documentation for GxP systems from Quality Control Units
  • Develop, implement and maintain computer system validation-related controlled documents to support the initiation, validation, operation and maintenance of GxP systems.
  • Assist with change controls, CAPAs, deviations, exceptions required as part of system validation efforts
  • Support system administrative & maintenance activities for Lab Systems


Required Skills for the Validation Engineer:

  • 6+ years’ experience in the pharmaceutical industry with GMP experience
  • Experience with validation of cGMP automation within FDA regulated environments
  • Understanding phases of Life Cycle Validation approach
  • Knowledge of GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, and Q10.
  • Ability to manage multiple projects
  • Bachelor's Degree in Engineering, Science, or related technological field


What’s in it for you?

  • Competitive compensation package
  • Full Benefits; Medical, Vision, Dental, and more
  • Opportunity to get in with an industry leading organization
  • Close-knit and team-oriented culture


Why IDR?

  • 25+ Years of Proven Industry Experience in 4 major markets
  • Employee Stock Ownership Program
  • Dedicated Engagement Manager who is committed to you and your success
  • Medical, Dental, Vision, and Life Insurance
  • ClearlyRated’s Best of Staffing® Client and Talent Award winner 10 years in a row


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