CSV Lead – SCADA & Historian Systems

Role: CSV Lead SCADA & Historian Systems
Location: Foster City, CA Onsite, 5 Days/Week
Company: Intellectt Inc
Employment Type: Long-Term Rolling Contract
Experience: 15+ Years
Payrate: $35/hr - $40/hr on W2
Industry: Biopharma / GMP Manufacturing

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.

Preferred:

• TetraScience or scientific/laboratory data platform validation experience.
• Cloud/SaaS GxP system qualification experience.
• Greenfield biologics/pharmaceutical facility experience.

Contact to Apply:
Name: Uzma Kousar Mohammed
Email:

uzma.kousar@intellectt.com

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.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k)retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.