CSV Validation Lead

Job Title: CSV Validation Lead
Location: Foster City, Onsite (5 days a week)

Job Summary
The CSV Validation Lead provides compliance leadership and governance for the validation lifecycle and ongoing state of control of GxP computerized systems, with primary focus on Environmental Monitoring Systems (GE iFix), Process Control/SCADA platforms (Rockwell FactoryTalk View–based systems and Inductive Automation Ignition–based systems), Building Management Systems and Data Historian systems. This role is accountable for risk-based validation strategy, review/approval of validation deliverables, and release governance for system implementations and changes, ensuring alignment with GAMP 5, 21 CFR Part 11, EU Annex 11, and cGMP expectations.

Key Responsibilities
Own and continuously improve the site CSV approach for assigned GxP systems, including validation strategy, stage-gate deliverables, and scalable risk-based practices aligned with modern GAMP guidance and quality risk management principles.
Maintain CSV templates and ensure consistent application across projects (e.g., validation plans, risk assessments, traceability, test strategy, summary reporting).
Serve as the CSV SME bridging Quality, IT/OT, Engineering, and Operations to enable compliant delivery while maintaining inspection readiness.
Review, challenge, and approve CSV deliverables for GxP systems, including (as applicable):
Validation/Compliance Plan / Strategy
URS, FRS, DS/CS
Requirements Risk Assessment (RRA) / Impact Assessments
Traceability Matrix (TM)
IQ/OQ/PQ protocols, deviations, and summary reports
Provide final CSV release/go-live recommendation/approval for system implementations and significant changes, ensuring documented evidence supports intended use and regulatory expectations.
Oversee execution readiness and evidence quality for qualification/testing (IQ/OQ/PQ), including review of test scripts, test deviations, corrective actions, and ensuring traceability to requirements.
Ensure validation documentation is complete, accurate, contemporaneous, and inspection-ready, with objective evidence organized for rapid retrieval during audits.
Provide CSV governance for change control impacting validated systems: review/approve impact assessments, required deliverable updates, test scope, and closure documentation.
Ensure changes maintain compliance with electronic records/e-signature controls (as applicable) and are supported by appropriate validation/verification.
Partner with Quality and site stakeholders to support deviations, CAPAs, investigations, and corrective actions affecting computerized systems; provide CSV input for RCA, remediation strategy, and effectiveness verification.
Provide CSV oversight for vendor activities (system integrators, service providers): ensure expectations, deliverable quality, and compliance evidence meet internal procedures and regulatory requirements.
May oversee CSV resources/contractors (assignment, coaching, deliverable review), ensuring consistent application of global CSV standards.
Lead CSV strategy for data migration and system decommissioning/retirement, including risk assessments, archival/retention requirements, and controlled transition to replacement systems.
Minimum Qualifications
Bachelor’s degree in computer science, Life Sciences, Engineering, or related discipline (or equivalent experience).
15+ years’ experience in CSV / IT validation within an FDA-regulated environment, with demonstrated ownership of validation governance and deliverable approval.
Strong working knowledge of:
GAMP 5 risk-based validation and lifecycle concepts
21 CFR Part 11 controls for trustworthy/reliable electronic records and e-signatures (as applicable)
EU Annex 11 principles (lifecycle validation, risk management, access control, audit trails, security, periodic review)
SDLC/CSV deliverables, traceability, test strategy, and inspection readiness practices
Proven ability to lead cross-functional decision-making in a regulated, matrixed environment (Quality/IT/Engineering/Operations).

Preferred Qualifications
Experience governing validation for GE iFix EMS, Rockwell FactoryTalk View, Ignition SCADA/PCS, Aveva Historian, Siemen’s Building Management Systems and/or DeltaV Distributed Control Systems implementation.
Ability to manage multiple priorities and deliver through others in a regulated environment
Experience with multi-site/global CSV governance models and harmonized templates/standards.
Prior people leadership and/or vendor management responsibility (including oversight of CSV contractors/consultants).
Familiarity with modern validation efficiency approaches (e.g., CSA-aligned risk-based thinking) as they relate to GAMP evolution.

Core Competencies
Compliance leadership & sound risk-based judgment (knowing where to be rigorous vs. pragmatic)
High documentation standards / GDP mindset and strong technical writing review capability
Stakeholder influence across Quality, IT/OT, Engineering, Validation, and Operations
Audit/inspection readiness orientation and ability to defend validation decisions with objective evidence
Ability to manage multiple priorities and deliver through others in a regulated environment
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