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
Click
here to apply!
|