Senior Validation Engineer

Role Overview

We are seeking an experienced Senior CSV Lead to manage validation and compliance activities for GxP-regulated computerized systems within a pharmaceutical manufacturing environment. The role requires strong expertise in Computer System Validation (CSV), Software Validation, IQ/OQ/PQ execution, Data Integrity, and regulatory compliance.

The successful candidate will lead validation lifecycle activities for manufacturing, laboratory, automation, and enterprise systems while ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements.

Key Responsibilities

• Lead end-to-end CSV lifecycle activities for GxP systems.
• Develop and execute IQ/OQ/PQ protocols and validation documentation.
• Review and approve URS, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
• Support validation of MES, LIMS, SCADA, ERP, laboratory, and manufacturing systems.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
• Manage change controls, deviations, CAPAs, and periodic reviews.
• Support audits and regulatory inspections.
• Collaborate with QA, IT, Engineering, Manufacturing, and Automation teams.
• Mentor junior validation engineers and support site projects.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• 10+ years of CSV experience in pharmaceutical or biotech manufacturing.
• Strong expertise in:
• Computer System Validation (CSV)
• Software Validation
• IQ/OQ/PQ
• Data Integrity
• GxP Compliance
• Hands-on experience with regulated manufacturing and laboratory systems.
• Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

Preferred

• Experience with MES, SCADA, LIMS, SAP, DeltaV, or similar GxP platforms.
• Exposure to cloud/SaaS validation and automation systems.
• ISPE, ASQ, PMP, or CSV-related certifications preferred.