Validation Engineer

at  LetsGetChecked

LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked’s end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives.

VALIDATION ENGINEER

We are seeking an experienced Validation Engineer to join our team and lead the development and maintenance of a robust Site Validation program. In this role, you will collaborate with key business stakeholders to ensure compliance with global regulatory requirements. The ideal candidate will possess a strong background in computer system validation, particularly within Class II/III medical device manufacturing, and will have a deep understanding of applicable global regulations and industry standards.

• Partner with key business stakeholders to develop policies and procedures necessary to lead the implementation and maintenance of a compliant, efficient and integrated Site Validation program.
• Draft, review and approve validation deliverables such as user requirements, technical design specifications, IQ/OQ/PQ scripts and reports, error logs, configuration document, traceability matrix and document 21 CFR Part 11 and EU Annex 11 compliance.
• Facilitate, prepare and execute Validation documents for Technical Operations, QA and R&D groups, as necessary.
• Develop Test Plan, Test Cases, Test Reports and Traceability Matrix as per business requirements
• Manage end to end testing / validation lifecycle and provide SME support on topics relevant to design Verification and validation (V&V) ,GxP, CSV, 21 CFR Part 11, EU Annex 11 etc.
• Coordinate with cross function departments to ensure Systems and software are validated for their intended use and solutions are implemented in an efficient and effective manner.
• Evaluate risks, maintain and implement quality systems to ensure compliance with applicable global regulatory requirements.
• Promote adherence to applicable policies and procedures governing computer systems, good documentation practices, and change management.