What are the responsibilities and job description for the CSV Engineer position at Katalyst Healthcares & Life Sciences?
Job Description
Job Description
Responsibilities :
- Draft and implement Quality System documentation designed to establish good validation practices within the organization.
- Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
- Design validation approaches, supported by appropriate statistical analyses, perform and / or coordinate all validation activities, analyze and assemble results, and draft validation reports.
- Perform Data Integrity Assessments and review systems against 21 CFR Part 11.
- Provide input on user and / or functional requirements of current and future processing equipment, and draft appropriate documentation.
- Additionally, interface with Manufacturers to ensure all relevant user and functional requirements are met.
- Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
- Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
- Review DeltaV software and specifications to design test protocols.
- Comply with all regulatory, corporate, and Quality System policies.
Requirements :
