What are the responsibilities and job description for the Validation Engineer position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- Validation & Qualification : Perform and support IQ / OQ for new fill-finish equipment and filling lines. Ensure that all equipment is installed and operating according to design specifications and regulatory standards.
- Commissioning Support : Assist with the commissioning of new equipment, ensuring all systems and equipment function properly before starting the qualification process.
- Documentation : Prepare, review, and maintain detailed validation protocols, reports, and documentation in alignment with Good Documentation Practices (GDP) and GMP regulations.
- Collaboration : Work closely with cross-functional teams, including engineering, quality, and operations, to ensure seamless integration and validation of new systems.
- Regulatory Compliance : Ensure that all validation activities meet GMP regulatory requirements, contributing to the safe and compliant operation of the facility.
- Troubleshooting : Identify and resolve issues that arise during the validation process, collaborating with the team to ensure all equipment operates within validated parameters.
Requirements :
