IDR is seeking a Validation Engineerto join one of our top clients in Newark, CA. This position is a 100% onsite role and a long-term 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
#INDT
Job Types: Full-time, Contract
Pay: $80.00 - $90.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Experience level:
- 10 years
- 11+ years
- 6 years
- 7 years
- 8 years
- 9 years
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
Ability to Commute:
- Newark, CA 94560 (Required)
Ability to Relocate:
- Newark, CA 94560: Relocate before starting work (Required)
Work Location: In person