CSV Lead – SCADA & Historian Systems

Hello,

I hope you're doing well.

My name is Pavani samboju, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a CSV Lead SCADA & Historian Systems 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

pavani.samboju@intellectt.com

Role: CSV Lead SCADA & Historian Systems
Location: Foster City, CA Onsite, 5 Days/Week
Experience: 15+ Years
Industry: Biopharma / GMP Manufacturing
Pay rate: 60$-70$/ hr

Key Skills:
CSV | GAMP 5 | CSA | 21 CFR Part 11 | Annex 11 | ALCOA+ | Ignition SCADA | AVEVA Historian | TetraScience | IQ/OQ/PQ | Data Integrity | Change Control | GMP

Job Summary:
We are seeking an experienced CSV Lead to lead risk-based validation activities for GxP computerized systems supporting a greenfield biologics manufacturing facility. This role will own validation strategy, deliverable approval, change control, and release readiness for Ignition SCADA, AVEVA Historian, TetraScience, and related system integrations.

Key Responsibilities:

Serve as Validation Lead and CSV approver for GxP computerized systems.

Develop and execute risk-based validation strategies aligned with GAMP 5, CSA, 21 CFR Part 11, EU Annex 11, and ALCOA+.

Review and approve validation plans, URS/FRS, risk assessments, traceability matrices, IQ/OQ/PQ protocols, deviations, and summary reports.

Lead validation of SCADA, Historian, scientific data platforms, and system interfaces.

Manage change control, impact assessments, regression testing, and release-readiness decisions.

Support data integrity assessments and qualification of cloud/SaaS and vendor-managed GxP systems.

Partner with Quality, Automation, IT/OT, Engineering, Manufacturing, and CQV teams.

Required Qualifications

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.

15+ years of CSV experience within GMP-regulated biopharmaceutical environments.

Proven experience as a CSV/Validation Lead and approver through the full validation lifecycle.

Strong knowledge of GAMP 5, CSA, 21 CFR Part 11, EU Annex 11, and ALCOA+.

Hands-on validation experience with Ignition SCADA or comparable GMP SCADA platforms.

Experience validating AVEVA or other process data historians.

Strong experience with URS, FRS, IQ/OQ/PQ, RTM, risk assessments, deviations, and validation summary reports.

Experience with Kneat, ValGenesis, or equivalent validation/document management systems.

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,
Pavani Samboju
Technical Recruiter
Intellectt Inc

pavani.samboju@intellectt.com

Direct: 732 993 4972
Desk number: 732 412 6999- Ext: 137