Computer Systems Validation Lead

RxCloud; San Francisco (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading healthcare technology company seeks a Computer Systems Validation Lead in San Francisco. This role requires over 10 years of experience with validation activities in GMP/GxP environments, and familiarity with regulatory documentation, including FDA 21 CFR Part 11. Ideal candidates will have a proven track record in developing validation documentation and experience with enterprise systems like SAP, Veeva, and Trackwise. Join our team to ensure compliance and support crucial validation strategies.

Qualifications

• 10+ years of experience in computer systems validation activities.
• 7+ years in GMP/GxP regulated environments.
• Experience with validation documentation and testing protocols.

Responsibilities

• Support and perform computer systems validation activities.
• Develop scalable validation strategies and documents.
• Conduct document reviews and ensure continuous compliance.

Skills

Computer systems validation

GMP/GxP experience

FDA 21 CFR Part 11

Documentation development

Test management tools

Tools

Microfocus ALM

ValGen

Veeva

Trackwise

Argus

Clinical systems

Quality systems

Job description

About the job Computer Systems Validation Lead

• At least 10 years of experience supporting and/or performing all aspects of computer systems validation activities including development of scalable validation strategies, documents, and perform document reviews
• At least 7 years prior experience in computer systems validation within GMP/GxP regulated environments
• Proven experience developing full validation documentation and testing protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
• Experience with FDA 21 CFR Part 11
• Experience with the validation of Enterprise systemsSAP and/or MES system Preferred. Validation ofLife sciences systems such as Veeva, Trackwise, Argus, Clnical, Qualitysystems highly desired.
• Broad understanding of the test managementTools, including experience and knowledge Microfocus ALM, ValGenesysetc preferred.
• Knowledge and experience around CSA highly preferred.