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.
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.
We’re on a Mission
In 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 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 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 Work
Our 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.
Key Responsibilities:
Validation Strategy & Technical Leadership
Regulatory Compliance & Inspection Readiness
System Lifecycle & Risk Management
Data Integrity & Part 11 Compliance
Modern Technology & CSA Adoption
Cross-Functional Leadership & Mentorship
Requirements:
Preferred Qualifications:
We recognize that no candidate may check every box. If your experience aligns with most of the requirements and you’re enthusiastic about the role, we would love to hear from you.
