Sr. Veeva/QMS Computer System Validation Engineer

Company: Adept Source
Location: Palo Alto
Posted on: November 19, 2023

Job Description:

Title: Sr. Veeva/QMS Computer System Validation Engineer

Type of role: Contract 5+ Months - Hybrid - 2 days on-site

Location of client: 200 Page Mill Rd. Palo Alto, CA 94304
(LOCAL Candidates ONLY, please)

Validation Engineer will assist us with qualification of Veeva QMA Systems as well as assist us validation of other applications. There are a few applications such as LIMS and Empower. In addition, there is the Azure platform and it is connected to the AWS platform at client.

This position requires a senior-level individual with strong experience in supporting computer system validation (CSV) efforts for infrastructure and applications used in GMP, GLP and/or GCP processes ensuring adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11 and Annex 11. The validation lead will be responsible for planning and tracking of all qualification tasks associated with qualifying the platforms above.

Requirements10+ years as a validation engineer/lead in Life Sciences industry
7+ years qualifying infrastructure and applications
Ability to drive validation deliverable reviews with the reviewers and approvers as well as outstanding communication skills
Ability to coordinate and execute multiple CSV projects in parallel
Develop plan, specs, test protocols, reports and procedural documents
Coordinate / communicate with other departments, SMEs
Ensure that all validation deliverables are prepared in accordance with internal guidelines, policies and procedures
Create, track and manage all validation project plans

Keywords: Adept Source, Palo Alto , Sr. Veeva/QMS Computer System Validation Engineer, IT / Software / Systems , Palo Alto, California