CSV Lead SCADA, Historian and Scientific Data Platform
Location: Foster City, CA (Onsite 5 days a week)
Long Term Rolling Contract
Job Summary:
The CSV Lead owns the risk-based validation strategy, deliverable approval, and release governance for the GxP computerized systems supporting a greenfield clinical biologics drug substance facility in Foster City. The role serves as the Validation Lead and validation approver for controlled changes to the Ignition SCADA and AVEVA Historian platforms in support of equipment and system-to-system integration, and for the GxP deployment and qualification of the TetraScience scientific data platform.
Systems in Scope
- Ignition SCADA: Controlled changes supporting environmental and utility monitoring, remote alarming, and new equipment integration.
- AVEVA Historian: Controlled changes supporting GMP data collection, contextualization, and trending.
- TetraScience: GxP deployment and qualification of laboratory and at-line instrument data integration.
- Interfaces: Validation of data flows between SCADA, historian, process control, and manufacturing execution systems.
Key Responsibilities- Serve as the designated Validation Lead and CSV approver for all validation deliverables, including validation plans, specifications, risk assessments, traceability matrices, qualification protocols, discrepancies, and validation summary reports.
- Own the risk-based validation strategy in alignment with GAMP 5, Computer Software Assurance, 21 CFR Part 11, EU GMP Annex 11, data integrity/ALCOA+ expectations, and client's CSV procedures.
- Determine, with documented justification, where supplier qualification, integrator FAT/SAT, and prior-deployment evidence may be leveraged within the risk-based testing strategy.
- Participate in requirements, design, and risk assessment workshops, and govern change control and change impact/regression assessments so the validated state is maintained throughout implementation.
- Define the data integrity/ALCOA+ assessment and approve the qualification approach for cloud-hosted and vendor-managed components, including where client-witnessed or client's-executed testing is required.
- Make and document release-readiness decisions, and coordinate with the CQV workstream so CSV and equipment qualification activities are sequenced correctly.
- Maintain alignment to the integrated project schedule, escalate validation risks and schedule impacts, and sustain validation ownership after go-live through periodic review and change control.
- Partner with Quality Assurance, Automation, Engineering, IT/OT Infrastructure, Manufacturing, System Owners, and service providers to resolve validation issues and finalize deliverables.
Required Qualifications- Bachelor's degree in engineering, Computer Science, Life Sciences, or a related technical discipline, with 15+ years of CSV experience in a GMP-regulated biopharmaceutical environment.
- Demonstrated experience as a Validation Lead and approver for GxP computerized systems through a full validation lifecycle, including greenfield or major capital projects.
- Working knowledge of GAMP 5 (2nd Edition), Computer Software Assurance, 21 CFR Part 11, EU GMP Annex 11, and data integrity/ALCOA+ principles, with practical experience applying risk-based testing and supplier leverage.
- Hands-on validation experience with Ignition or comparable SCADA platforms in a GMP environment, including configuration, alarm, historization, and security qualification.
- Experience validating process data historians, including asset framework/tag structure, collection interfaces, and historized data integrity verification.
- Experience authoring, reviewing, and approving the full CSV deliverable set: validation plans, URS, FRS, design/configuration specifications, risk assessments, traceability matrices, IQ/OQ/PQ protocols, discrepancies, and validation summary reports.
- Experience with electronic validation/document management platforms (Kneat, ValGenesis, or equivalent) and GMP change control systems.
- Strong written and verbal communication skills, with the ability to drive decisions across Quality, Automation, IT/OT, Engineering, and Manufacturing.
Preferred Qualifications- Experience validating laboratory or scientific data integration platforms, instrument connectivity, and data parsing/contextualization workflows.
- Experience qualifying cloud-hosted or SaaS-delivered GxP systems, including hosting model evaluation and failover/disaster recovery qualification.
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.