Join to apply for the Instrument Validation Engineer - Lab IT role at Katalyst CRO
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Join to apply for the Instrument Validation Engineer - Lab IT role at Katalyst CRO
- Bachelor's degree in engineering, Life Sciences, Computer Science, or a related field.
- Minimum of 3-5 years of experience in validation within the pharmaceutical, biotech, or medical device industries.
- Develop and execute validation protocols (IQ, OQ, PQ) for the migration of lab instruments from Windows 7 to Windows 10.
- Conduct thorough assessments of existing lab instruments to identify compatibility issues and ensure all instruments are supported on Windows 10.
- Ensure all migration activities comply with GxP regulations and maintain system validation throughout the process.
- Perform risk assessments and develop mitigation strategies to address potential issues during the migration.
- Maintain detailed documentation of the validation process, including validation plans, test scripts, and validation reports.
- Work closely with IT, QA, and lab teams to coordinate validation activities and address any issues that arise.
- Proficiency in Windows 7 and Windows 10, knowledge of GxP compliance, experience with lab instruments, and strong troubleshooting skills.
- Excellent verbal and written communication skills, with the ability to explain technical concepts to non-technical users.
- Strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving issues.
- Experience with automated validation tools and software.
- Certification in validation or quality assurance (e.g., ASQ Certified Quality Engineer).
Seniority level
Seniority level
Associate
Employment type
Employment type
Contract
Job function
Industries
Pharmaceutical Manufacturing
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