Job Description & How to Apply Below
Learn more about working for Val Genesis, the de facto standard for paperless validation in Life Sciences:
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 Dev Ops 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.
Requirements
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field (advanced degree preferred).
10+ years experience in pharmaceutical GxP software validation / CSV / CSA / Cleaning Validation.
Proven experience as a lead or principal SME in software, equipment, and cleaning validation.
Strong knowledge of FDA, EMA, and global GMP expectations.
Demonstrated success leading regulatory inspections related to computerized systems.
Excellent communication, leadership, and stakeholder management skills.
Preferred Qualifications
Experience with SAP S/4
HAN…
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