Senior CSV Engineer

The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.

Responsibilities

• Lead and execute computer system validation (CSV) activities for GxP-regulated systems.
• Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations.
• Define and implement risk-based validation strategies for computerized systems.
• Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems.
• Support system implementations, upgrades, and decommissioning activities from a validation perspective.
• Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment.
• Lead change control assessments and determine validation impact of system changes.
• Ensure data integrity (ALCOA+) compliance across validated systems.
• Support audits and regulatory inspections by providing validation documentation and system justification.
• Mentor and guide junior CSV engineers and validation team members.
• Drive continuous improvement of validation processes, templates, and standards.
• Review vendor documentation and ensure systems meet regulatory expectations prior to deployment.

Requirements:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 5-10+ years of experience in Computer System Validation (CSV) or validation engineering.
• Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
• Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
• Strong understanding of risk-based validation and data integrity principles.
• Experience supporting regulatory audits and inspections.

Preferred Skills:

• Experience with systems such as LabWare, SAP, Oracle, Veeva, TrackWise, Empower.
• Knowledge of cloud-based validation and SaaS systems.
• Experience in data integrity remediation projects.
• Strong technical writing and documentation skills.
• Ability to lead cross-functional validation projects.

Key Competencies:

• Strong leadership and SME-level expertise in CSV.
• Excellent analytical and risk assessment skills.
• Strong communication and stakeholder management.
• Ability to manage multiple validation projects simultaneously.
• High attention to detail and regulatory compliance mindset.