Katalyst HealthCares and Life Sciences

Compensation

Full Description

Job Description: We are seeking an experienced Validation Lead to oversee and lead validation activities in compliance with GMP (Good Manufacturing Practice) and GxP (Good Clinical/ Laboratory Practice) regulations. The ideal candidate will have a strong background in managing validation processes for systems, equipment, and processes within regulated environments, ensuring compliance, quality, and safety standards are met. Responsibilities: • Lead and manage validation activities for systems, equipment, and processes to meet GMP/GxP standards. • Develop and execute validation plans, protocols, and reports. • Coordinate with cross-functional teams (QA, IT, Operations) to ensure validation deliverables are completed on time. • Perform risk assessments and gap analysis to ensure compliance with regulatory requirements. • Provide technical expertise in validation processes and troubleshooting issues. • Ensure all validation documentation is accurate, up-to-date, and in compliance with regulatory guidelines. • Support internal audits and inspections related to validation. • Mentor and guide junior team members in validation activities. Requirements: • At least a bachelor's degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or a closely related field is required for the project • Mandatory Skills: GMP/GXP.