Validation Engineer
Dotmatics
Our Why At Dotmatics
At Dotmatics, we believe science, data, and decision-making must be deeply intertwined for innovation to thrive.
Our Portfolio includes Luma, LumaLab Connect, ELN Platform, Graphpad Prism, Geneious, SnapGene, Protein Metrics, OMIQ, FCS Express, LabArchives, NQuery, EasyPanel, MStar, SoftGenetics and Virscidian.
We have a vision for a new Lab of the Future that will change the future of scientific research.
We have created the world’s most comprehensive digital science platform – best-of-breed software applications already used by more than 2 million scientists, together in a single ecosystem united by a powerful, flexible enterprise data platform. This is not flat data buried away in digital graveyards. This is dynamic, multi-dimensional decision-making.
Scientific enterprises need a new level of effectiveness to achieve tomorrow’s breakthroughs. Illness will not wait. The biosphere will not wait. We are tireless in our vision, because the time for innovation is now.
Shaping the Future of Science At Dotmatics
Our global team of more than 800 colleagues are dedicated to supporting our customers in over 180 countries. Together, with our scientific community of users, we accelerate scientific innovation in order to make the world a healthier, cleaner, and safer place to live.
You’ll join a collaborative, global team pushing the boundaries of scientific innovation. Your ideas and efforts will have a tangible impact, accelerating scientific progress and discovery. We offer a dynamic, remote-friendly environment that fosters high integrity and collaboration, empowering you to excel. Dotmatics is a company built by scientists, for scientists. Combined, we are now the world’s largest cloud-based scientific research R&D platform. We need your help to keep growing and pioneering the future.
We are Science Driven. We are Customer Centric. We are Better Together.
What do we need
As a Validation Engineer you will be responsible for developing and executing validation artifacts for Dotmatics Luma platform and its internal systems operating ensuring that our software systems meet GxP requirements through comprehensive validation activities, working closely with Quality Management, Engineering, and Product teams to maintain compliance with FDA regulations and industry standards.
In this role you will get to:
- Develop and execute validation protocols (IQ/OQ/PQ) for software systems and tools used in GxP environments
- Author and maintain validation documentation including validation master plans, protocols, reports, and standard operating procedures
- Follow comprehensive validation plans following GAMP 5 principles, including risk-based approaches to validation activities
- Ensure all validation activities comply with 21 CFR Part 11, GAMP 5, ISO 9001 and applicable FDA guidance
- Maintain validation documentation in accordance with quality management system requirements
- Support audit and inspection readiness through comprehensive validation records
- Partner with Software Engineering, Product Management and Quality Management on developing and reviewing validation artifacts
- Support Change Control activities and assess validation impact of system changes
We are looking for people who can ensure ongoing compliance through periodic system reviews, support revalidation and regression testing for system changes, participate in CAPA investigations, and drive continuous improvement of validation processes and efficiency.
The key skills we are looking for:
- Experience in software validation, computer system validation (CSV), or related quality/compliance role within a regulated life sciences environment (pharma, biotech, or medical device)
- Strong understanding of GAMP 5 principles and risk-based validation approaches
- Working knowledge of 21 CFR Part 11 requirements for electronic records and signatures
- Familiarity with ISO 9001 quality management system principles
You may also have:
- Bachelor's degree in Computer Science, Biology, Chemistry, Engineering, or related technical field, preferred but not required
- QMS and regulatory compliance experience
- Understanding of software development lifecycle (SDLC) and Agile methodologies
- Experience with validation of cloud-based systems, SaaS applications, or commercial off-the-shelf (COTS) software
Research shows us the confidence gap and imposter syndrome can get in the way of meeting outstanding candidates, so please don’t hesitate to apply — we’d love to hear from you.
By submitting your application, you agree that Dotmatics may collect your personal data for recruiting, global organization planning, and related purposes. Dotmatics Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Dotmatics use of your personal information.
Dotmatics is an equal opportunity employer. We are a welcoming place for everyone, and we do our best to make sure all people feel supported and connected at work.