Job Details

Sr. CSV Engineer

Location

Foster City, CA - Onsite, 5 days per week

Position Summary

The Senior Computer Systems Validation Engineer will support the validation lifecycle and compliant operation of GxP computerized systems, with primary emphasis on Environmental Monitoring Systems such as GE iFix and Process Control/SCADA platforms, including Rockwell FactoryTalk View-based systems and Inductive Automation Ignition-based systems. This role leads validation documentation, executes qualification activities, supports change control, and partners with cross-functional teams to maintain a controlled state aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, and cGMP expectations.

Key Responsibilities

• Lead the authoring, review, and maintenance of CSV deliverables for GxP systems, including User Requirements Specifications, Functional Requirements Specifications, Design/Configuration Specifications, Traceability Matrices, Requirements Risk Assessments, and IQ/OQ/PQ protocols with associated execution evidence.
• Execute qualification protocols, including IQ/OQ/PQ, and ensure all supporting documentation is complete, accurate, and inspection-ready.
• Drive risk-based validation approaches consistent with GAMP 5 and SDLC best practices.
• Author and manage change control records, including impact assessments, required documentation updates, and implementation tasks.
• Ensure system changes are implemented in a compliant manner, including appropriate verification or qualification activities and closure documentation.
• Support audit readiness by maintaining organized validation packages, clear traceability, and objective evidence.
• Develop data migration and decommissioning strategies for legacy systems, including risk assessments and retention or archival considerations.
• Author validation deliverables that support system retirement activities and ensure controlled transition to replacement systems.
• Collaborate with Quality and site stakeholders to support deviations, CAPAs, investigations, and corrective actions affecting computerized systems.
• Provide CSV input for root cause analysis, remediation strategy, and effectiveness verification, as applicable.
• Maintain system-specific operational documentation, including SOPs, work instructions, forms/templates, training plans, and other business-enabling documentation.

Minimum Qualifications

• Bachelor's degree in Computer Science, Life Sciences, Engineering, or a related field, or equivalent professional experience.
• 7+ years of experience validating computerized systems in an FDA-regulated environment.
• Strong working knowledge of GAMP 5 validation methodology and risk-based validation approaches.
• Working knowledge of 21 CFR Part 11 and EU Annex 11, including application to environmental monitoring and/or control systems.
• Strong understanding of CSV deliverables and SDLC best practices.
• Knowledge of cGMP requirements and inspection readiness expectations.

Preferred Qualifications

• Experience supporting validation for GE iFix EMS, Rockwell FactoryTalk View, Ignition SCADA/PCS, Aveva Historian, Siemens Building Management Systems, and/or DeltaV Distributed Control Systems implementations.
• Experience developing validation approaches for multi-site or global implementations.
• System administration experience is preferred but not required.

Core Competencies

• Excellent technical writing skills and strong documentation discipline.
• Ability to collaborate and manage stakeholders across Quality, IT, Validation, Engineering, and Operations.
• Risk-based decision-making with strong attention to inspection readiness.
• Ability to manage multiple priorities and deliver effectively in a regulated environment.