Validation Engineer (341644)
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
Sr. Principal Security Engineer
Demonstrated experience in using Endpoint Detection and Response software (SentinelOne, Crowdstrike, Defender ETC. As a Senior Principal Security Engineer, you will play a critical role in our cyber security function to ensure enterprise and client data is secure. Share such knowledge, to resolve is...
Lead Automation QA Engineer
A company is looking for a Lead Automation QA Engineer. ...
Network OS QA/Qualification Engineer
Network OS QA/Qualification Engineer (note - this is NOT network engineer position). Job Title: Network OS QA/Qualification Engineer. Work-experience 8+ years of Networking-domain ( Operations, Testing/QA, Development ). ...
Associate Engineer II/ Engineer I, LNP Process Development
The Associate Engineer/Engineer will work as part of a team, under the direction of the group leader/manager, to conduct laboratory experiments to support the development of robust scalable LNP-encapsulated nucleic acids formulations and manufacturing processes, including lab-scale process developme...
Quality Engineer
In this role, you will be supporting the Quality department to ensure products are being produced in accordance with appropriate data, maintaining the Quality Management System (QMS), and participating in MRBs, amongst other responsibilities. Technical or Engineering degree is a MUST. Quality Assura...
No C2C- Only Local -Manufacturing Test Engineer
Learn test best practices and drive development and implementation of test and tester. Develop end-to-end testing strategies and drive to continuously improve the world class manufacturing test processes. Owns testing specifications for complete test coverage of design features utilizing data-driven...
Manager, Quality Engineer
Bachelor’s degree in quality, mechanical or industrial engineering, Quality Management, or related field. We are seeking a dedicated and detail-oriented Quality Engineer with expertise in packaging and labeling. Minimum of 3-5 years of experience in quality engineering with a focus on packaging and ...
Senior SOC Validation Engineer
SOC validation engineers use the silicon evaluation platform, Software, and other test equipment to test the functionality and design of products, programs, and other tools. The validation engineer is responsible for ensuring the compliance of a product with its specifications. Xconn-technologies is...
Remote Software Engineer
Job Title: Remote Software Engineer. As part of our commitment to flexible working arrangements, we are seeking a talented Remote Software Engineer to join our team and contribute to our exciting projects. We are looking for an experienced and motivated Remote Software Engineer to join our growing t...
Plating Process Engineer
Under the direction of the Director of Plating Process Development, the Plating Process Development Engineer is responsible for developing and delivering new strategies for improving and optimizing plating and wet etch process and procedures; designing and conducting moderately complex wafer experim...