Principal Software Validation Specialist

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ValGenesis is seeking a Principal Software Validation Subject Matter Expert to lead GxP software validation across manufacturing, lab, and quality systems, accountable for cleaning validation programs, risk-based lifecycle strategies, and CSA adoption. The role requires 10+ years in pharmaceutical CSV/CSA, knowledge of FDA/EMA/GMP, leading regulatory inspections, and cross-functional leadership to mentor teams. Location: Toronto onsite with a hybrid schedule of 3 days per week. Preferred experience with SAP S/4HANA, cloud LIMS, SaaS, AI/ML, CSA frameworks, and certifications. To apply, tailor your resume and a concise cover letter detailing impact on risk-based validation, data integrity, and audits; provide concrete examples of enterprise validation, regulatory responses, and stakeholder management. Emphasize communication and leadership for executive audiences.

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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.

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.

Preferred Qualifications:

• 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).

Key Competencies

• Regulatory judgment and risk-based decision making
• Deep GxP and data integrity expertise
• Influential leadership and executive communication
• Ability to balance compliance, speed, and business needs
• Strategic thinking and technical depth
• Attention to detail with a systems-level perspective

We’re on a MissionIn 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard.Today, we continue to push the boundaries of innovation ― enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations.
The Team You’ll JoinOur customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission.​We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done.We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward.We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader.​
How We WorkOur hybrid schedule is 3 days per week, within a reasonable commuting distance to our Toronto office. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.