What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
- Responsible for writing protocols, reports, SOPs, and other formal documents consistent with cGLP requirements as related to qualification and validation activities.
- Responsible for executing qualification protocols for equipment, utilities, facilities, cleaning, and manufacturing processes with proper documentation as related to qualification and validation activities.
- Responsible for assisting in the review and approval of equipment, facilities and other modifications under change control as related to qualification and validation activities.
- Responsible for remaining current on validation practices in the pharmaceutical industry and provide expert advice on validation requirements to other employees.
- Responsible for providing information to QA and other departments on technical aspects of qualified and validated systems.
- Responsible for participating in the selection and qualification of new equipment.
- Responsible for assisting in the production of worldwide regulatory compliant documentation of validation and representing the department in meetings or inspections by regulatory authorities as needed as related to qualification activities.
- Responsible for performing Annual and Quarterly Periodic Reviews as per Client's compliance schedule as related to qualification activities.
- Responsible for executing and maintaining all equipment, facilities, and utilities in the compliant state throughout each change and each periodic review as related to qualification activities.
- Includes all summary reports and periodic review documents that must be drafted for each piece of equipment and utility.
- Responsible for providing technical input for the qualification and validation of laboratory equipment as well as facilities.
- Responsible for providing an internal technical support role in engineering by designing and executing necessary studies to support qualification and validation of equipment and facilities.
Requirements :
