Senior GxP Systems & Validation Specialist (Biotechnology)
Not Disclosed•ContractorHybrid
location_on231, Ottawa Street, San Mateo, San Mateo County, California, 94401, United States
About the Role
We are seeking a Senior GxP Systems & Validation Specialist to join a world leader in life sciences and biotechnology. Based in Foster City, CA, this hybrid role is critical for maintaining the integrity of our regulated environment. You will serve as the guardian of our GxP and business applications, ensuring they remain compliant, reliable, and efficient through rigorous Computer System Validation (CSV) and operational management.
In this position, you will bridge the gap between technical infrastructure and quality compliance. Your day-to-day involves leading CSV lifecycle activities, managing quality events like Change Controls and CAPAs, and supporting cloud infrastructure transitions. You will collaborate with cross-functional teams to drive operational excellence, utilizing Agile methodologies to keep our systems audit-ready and optimized for continuous improvement.
Work location
Work model: Hybrid
231, Ottawa Street, San Mateo, San Mateo County, California, 94401, United States
San Mateo, California
Key Responsibilities
- check_circleAdminister and support GxP and business applications including incident resolution and access management
- check_circleLead CSV lifecycle activities including protocol authoring, execution, and audit readiness
- check_circleManage quality events such as Change Controls, Deviations, and CAPAs within QMS platforms
- check_circlePerform system maintenance activities including backup/restore testing and disaster recovery validation
- check_circleSupport cloud operations, system upgrades, migrations, and security patching on AWS or Azure
- check_circleLead Agile and Scrum activities using JIRA and Azure DevOps
- check_circleMaintain dashboards, reports, and training documentation to support continuous improvement
- check_circleCollaborate with cross-functional teams to drive compliant system operations and operational excellence
Requirements
- verifiedBachelor's degree in Computer Science, IT, or related field
- verified8+ years of experience in GxP system administration and Computer System Validation (CSV)
- verifiedExperience with cloud platforms (AWS/Azure)
- verifiedHands-on experience with ValGenesis, Veeva QMS, or equivalent
- verifiedProficiency with JIRA, Azure DevOps, MS Visio
Nice to Have
Exposure to SAP ecosystems. Experience with automation/process optimization (RPA).
Benefits & Perks
check_circleMedical, Dental, and Vision insurancecheck_circlePaid Sick leavecheck_circle401K retirement plan
Similar Job Opportunities
Skills, education and keywords
Skills: GXP, Computer System Validation, CSV, Valgenesis, Veeva QMS, Aws, Azure, Jira, Azure Devops, MS Visio.
Education: Bachelor's degree in Computer Science, IT, or related field required.
Frequently asked questions about Senior GxP Systems & Validation Specialist (Biotechnology) at DAWAR CONSULTING INC
What does a Senior GxP Systems & Validation Specialist (Biotechnology) at DAWAR CONSULTING INC do?expand_more
Day-to-day, the Senior GxP Systems & Validation Specialist (Biotechnology) at DAWAR CONSULTING INC will administer and support gxp and business applications including incident resolution and access management; lead csv lifecycle activities including protocol authoring, execution, and audit readiness; manage quality events such as change controls, deviations, and capas within qms platforms; and perform system maintenance activities including backup/restore testing and disaster recovery validation.
What are the requirements for this Senior GxP Systems & Validation Specialist (Biotechnology) role?expand_more
To qualify for the Senior GxP Systems & Validation Specialist (Biotechnology) at DAWAR CONSULTING INC position, applicants should have: Bachelor's degree in Computer Science, IT, or related field; 8+ years of experience in GxP system administration and Computer System Validation (CSV); Experience with cloud platforms (AWS/Azure); Hands-on experience with ValGenesis, Veeva QMS, or equivalent; and Proficiency with JIRA, Azure DevOps, MS Visio.
Where is the Senior GxP Systems & Validation Specialist (Biotechnology) role at DAWAR CONSULTING INC located?expand_more
Senior GxP Systems & Validation Specialist (Biotechnology) at DAWAR CONSULTING INC is based in 231, Ottawa Street, San Mateo, San Mateo County, California, 94401, United States. This is a hybrid role.
Is this Senior GxP Systems & Validation Specialist (Biotechnology) job remote, hybrid, or on-site?expand_more
DAWAR CONSULTING INC has listed this Senior GxP Systems & Validation Specialist (Biotechnology) role as hybrid.
How much experience is required for this Senior GxP Systems & Validation Specialist (Biotechnology) role?expand_more
Senior GxP Systems & Validation Specialist (Biotechnology) at DAWAR CONSULTING INC typically requires 8+ years of relevant experience at the senior level.
What skills do you need for the Senior GxP Systems & Validation Specialist (Biotechnology) role at DAWAR CONSULTING INC?expand_more
Key skills for Senior GxP Systems & Validation Specialist (Biotechnology) at DAWAR CONSULTING INC include GXP; Computer System Validation; CSV; Valgenesis; Veeva QMS; Aws; Azure; and Jira.
What education is required for Senior GxP Systems & Validation Specialist (Biotechnology) at DAWAR CONSULTING INC?expand_more
Educational requirements for this role: Bachelor's degree in Computer Science, IT, or related field required.
What category does the Senior GxP Systems & Validation Specialist (Biotechnology) role belong to?expand_more
Senior GxP Systems & Validation Specialist (Biotechnology) at DAWAR CONSULTING INC is part of the it job category on Recrutus.