CSV Lead

Hello,

I hope you're doing well.

My name is Soundarya, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for CSV Lead based in Foster City, CA with one of our prestigious clients. I would
love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at soundarya.kondra@intellectt.com

Job Title: CSV Lead
Location: Foster City, CA
Work Arrangement: Onsite
Experience Level: 7-8 years
Pay rate: $60/hr - $70/hr

Job Summary:
We are seeking an experienced CSV Lead to own the risk-based validation strategy and approval of GxP computerized systems supporting a clinical biologics manufacturing facility. The role will lead validation activities for Ignition SCADA, AVEVA Historian, TetraScience, and system interfaces while ensuring compliance with GMP and data integrity requirements.

Key Responsibilities:

• Lead and approve CSV deliverables throughout the complete validation lifecycle.
• Develop and execute risk-based validation strategies aligned with GAMP 5, CSA, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+.
• Lead validation of Ignition SCADA, AVEVA Historian, TetraScience, and related system interfaces.
• Review/approve URS, FRS, risk assessments, traceability matrices, IQ/OQ/PQ, discrepancies, and validation summary reports.
• Manage change control, impact assessments, regression testing, and release readiness.
• Validate data integrity, alarms, security, historization, interfaces, and system-to-system data flows.
• Partner with Quality, Automation, Engineering, IT/OT, Manufacturing, and system vendors.
• Support supplier qualification, FAT/SAT, cloud/SaaS validation, and post-go-live change control.

Required Qualifications:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 15+ years of CSV experience in a GMP-regulated biopharmaceutical environment.
• Proven experience as a CSV/Validation Lead and approver for GxP computerized systems.
• Strong knowledge of GAMP 5 (2nd Edition), CSA, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+.
• Hands-on experience validating Ignition or similar SCADA platforms in a GMP environment.
• Experience with AVEVA Historian or other process data historians.
• Experience with CSV platforms such as Kneat, ValGenesis, or equivalent.
• Strong understanding of change control, risk assessment, and validation documentation.

Preferred:

• Experience with TetraScience, laboratory data integration, instrument connectivity, or scientific data platforms.
• Experience validating cloud/SaaS GxP systems, including disaster recovery and failover.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Thanks & Regards,
Soundarya
Technical Recruiter
Intellectt Inc
Soundarya@intellectt.com
Direct: 732 204 6899
Desk number: 732 412 6999 Ext: 247