Job Title

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 riskbased, lifecycledriven approaches aligned with GAMP 5 and FDA CSA guidance. Key Responsibilities Validation Strategy & Technical Leadership Act as the enterpriselevel 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 trackandtrace systems Establish and maintain validation SOPs, templates, and standards aligned with GAMP5 and CSA principles Establish scientifically sound, riskbased 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 highrisk, 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 Intended use and GxP impact assessments Risk assessments (data integrity, patient safety, product quality) Test strategy definition (IQ/OQ/PQ or CSAbased testing) Traceability and validation summary reports Product and equipment risk assessments Worstcase product and residue selection Acceptance limit calculations (HBEL/PDEbased) 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 CrossFunctional 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 Bachelors 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/4HANA, cloud LIMS, MES, or enterprise quality platforms Validation of cloudbased, SaaS, AI/ML, or cybersecurityrelated systems Handson 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 riskbased 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 systemslevel perspective We recognize that no candidate may check every box. If your experience aligns with most of the requirements and youre enthusiastic about the role, we would love to hear from you. Were on a Mission In 2005, we disrupted the life sciences industry by introducing the worlds first digital validation lifecycle management system. ValGenesis VLMS revolutionized compliancebased 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 endtoend digital transformation platform. We combine our purposebuilt systems with worldclass consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team Youll Join Our 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 humanitys 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. Were in it to win it. Were on a path to becoming the number one intelligent validation platform in the market, and we wont settle for anything less than being a market leader. How We Work Our hybrid schedule is 3 days per week, within a reasonable commuting distance to our Toronto office. We believe that inperson interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. ValGenesis is an equalopportunity employer that makes employment decisions on the basis of merit. Our goal is to have the bestqualified 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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. In alignment with our commitment to pay transparency, we are pleased to share the base salary range above for this fulltime position. This role may also be eligible for additional incentive or bonus compensation, where applicable. The final base salary offered will be determined based on the selected candidates skills, experience, qualifications, and geographic location. Our compensation ranges are thoughtfully designed and benchmarked according to the specific role, level, and market location to ensure fairness and competitiveness. This position is being posted to fill a newly created role. Job Location: 145 King Street West, Suite 1720, Toronto, ON, M5H 1J8 #J-18808-Ljbffr