Principal Software Validation Specialist

ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle.

Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.valgenesis.com/about

The Principal Software Validation Subject Matter Expert (SME) provides strategic and technical leadership for validation of GxP computerized systems and governance of cleaning validation programs across pharmaceutical manufacturing operations. This role ensures systems are validated and maintained in compliance with FDA, EMA, and global regulatory requirements using risk-based, lifecycle-driven approaches aligned with GAMP 5 and FDA CSA guidance.

Key Responsibilities:

Validation Strategy & Technical Leadership

• Act as the enterprise-level SME for GxP software validation and computerized system validation (CSV/CSA).
• Define and govern validation strategies for enterprise, manufacturing, laboratory, and quality systems, including serialization, labeling, and track-and-trace systems
• Establish and maintain validation SOPs, templates, and standards aligned with GAMP5 and CSA principles.
• Establish scientifically sound, risk-based approaches for:
• Equipment cleaning (shared and dedicated)
• Manual and automated cleaning processes (CIP/SIP/COP)
• Campaign and product changeover strategies
• Lead validation approach decisions for high-risk, novel, or complex systems.

Regulatory Compliance & Inspection Readiness

• Ensure compliance with global regulations and guidance, including:
• FDA 21 CFR Parts 11, 210, 211
• EU GMP Annex 11
• ICH Q9 (Quality Risk Management)
• GAMP 5 (2nd Edition) and FDA CSA guidance
• Serve as primary SME during FDA, EMA, MHRA, and internal audits.
• Provide authoritative responses to regulatory observations related to computerized systems.
• Interpret new or evolving regulations and translate them into actionable validation practices.

System Lifecycle & Risk Management

Oversee validation activities, including cleaning validation, across the full system lifecycle:

• Intended use and GxP impact assessments
• Risk assessments (data integrity, patient safety, product quality)
• Test strategy definition (IQ/OQ/PQ or CSA-based testing)
• Traceability and validation summary reports
• Product and equipment risk assessments
• Worst-case product and residue selection
• Acceptance limit calculations (HBEL/PDE-based)
• Method selection and validation coordination
• Validation execution, reporting, and continued verification
• Ensure ongoing compliance through change control, periodic review, and system retirement activities.

Data Integrity & Part 11 Compliance

• Ensure systems meet ALCOA+ data integrity principles.
• Ensure accurate, complete, and compliant documentation supporting cleaning validation activities.

Define controls for:

• Electronic records and electronic signatures
• Audit trails and system security
• Backup, recovery, and disaster recovery

Modern Technology & CSA Adoption

Lead validation approaches for:

• Cloud and SaaS GxP systems
• Agile and DevOps environments
• Automated testing and continuous validation
• Drive adoption of Computer Software Assurance (CSA) to reduce validation burden while maintaining compliance.

Cross-Functional Leadership & Mentorship

• Collaborate with Quality, IT, Engineering, Manufacturing, QC Labs, and Regulatory Affairs.
• Mentor validation engineers and quality professionals.
• Influence senior leadership on validation risk, compliance posture, and remediation strategies.