What are the responsibilities and job description for the Validation Engineer position at Katalyst CRO?
Roles & Responsibilities
- 10 years.
- Experience with CSV, upgrades, enhancements, and operational support procedures.
- Demonstrated ability to understand, analyze and document complex business processes, translate business needs and functional requirements into technical or process-driven solutions.
- Experienced and self-directed individual able to work independently and collaboratively in matrixed team environment, lead business users/stakeholders and DTE team members to complete assigned workstream tasks in a timely manner and with expected level of quality.
- Strong communication, interpersonal and collaborative skills.
- Solid analytical and problem-solving abilities.
- Experience in system configurations for a CSV system implementation, including sample management, results analysis, lab workflow, release & stability management, Lab Execution Systems (LES) / Electronic Lab Notebooks (ELN) etc.
- Document and present complex issues, design options and solutions to a variety of audiences.
- Participate in the computer system validation (CSV) planning and execution of the solutions, authoring and/or contributing to key system Life cycle (SLC) & CSV deliverables.
- Partner with managed services team members and peers for platform and database support, as well as technical development for enhancements and projects.
- Work closely with Compliance, Internal Audit and Quality Assurance groups as needed to ensure compliance with GxP regulations, as well as our DTE system lifecycle and change management.