Join to apply for the Validation Engineer II role at Katalyst CRO.
Responsibilities:
- Develop validation plans, qualification protocols, compile and analyze data, draft summary reports, and review validation documentation to ensure systems are qualified according to regulatory standards.
- Ensure all validation documentation meets or exceeds regulatory expectations.
- Hands-on experience with validation of equipment and computer systems, including computerized systems validation.
- Work independently on validation discrepancies or investigations.
- Perform temperature mapping studies.
- Perform other duties as assigned.
Requirements:
- 2-5 years of experience in validation or related fields.
- Experience with equipment and computer systems qualification, including controlled temperature units.
- Strong understanding of regulatory standards and documentation practices.
- Ability to work independently, manage multiple priorities, and resolve validation issues.
- Excellent analytical and technical writing skills.
Seniority level: Associate
Employment type: Contract
Industry: Pharmaceutical Manufacturing
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