What are the responsibilities and job description for the Validation Engineer position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument.
- Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution.
- Ensure deliverables meet the overall facility milestones.
- Perform and support periodic assessment review and revalidation activities.
- Ensure deliverables are executed per client Validation Master Plan and other required SOPs.
- Ensure discrepancies are resolved and closed out in a timely manner.
- Develop testing templates and qualification protocols using paper and electronic validation systems (Kneat).
- Perform system impact assessments, risk assessments.
- Support development and review of engineering lifecycle documents for new and existing equipment.
- Maintain the Validation Master Plan, engineering lifecycle documents, and validation program SOPs.
- Support validation activities related to tech transfer projects for all manufacturing suites.
- Support site capital projects and other improvement projects.
- Promote engineering best practices, Elevate SOPs, and cGMP regulations.
- Work with Quality Assurance to ensure all validation activities are in compliance.
- Support and execute Change Controls to qualified facilities, equipment, and utilities.
Requirements :
