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About the role
- Principal Software Validation Subject Matter Expert leading GxP validation efforts for life sciences at ValGenesis. Ensuring compliance with FDA and global regulatory requirements in a hybrid environment.
Responsibilities
- Provides strategic and technical leadership for validation of GxP computerized systems and governance of cleaning validation programs across pharmaceutical manufacturing operations.
- 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.
- 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.
- Lead validation approach decisions for high-risk, novel, or complex systems.
- Ensure compliance with global regulations and guidance during inspections.
- Mentoring validation engineers and quality professionals.
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 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.
- Experience with SAP S/4HANA, cloud LIMS, MES, or enterprise quality platforms.
- Validation of cloud-based, SaaS, AI/ML, or cybersecurity-related systems.
- Hands-on experience implementing CSA frameworks.
- Experience influencing validation strategy at an enterprise or global level.
- Familiarity with data integrity remediation programs.
- Professional certifications (ASQ CQA, PMP, RAPS, or equivalent).
Benefits
- In alignment with our commitment to pay transparency, we are pleased to share the base salary range above for this full-time position. This role may also be eligible for additional incentive or bonus compensation, where applicable.
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