Senior Computerized Systems Validation Engineer
4 weeks ago
The Senior Computerized Systems Validation Engineer will be responsible for overseeing the validation of computerized systems at all applicable points of the lifecycle, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities- Provide oversight of validation activities and lead the development and approval of validation documentation
- Conduct impact assessments of proposed changes to computerized systems
- Collaborate with project teams to determine which elements should be validated
- Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure
- Master's degree in Computer Science, Life Sciences, Engineering, or similar discipline
- 3+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry
- Knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements, and FDA industry regulations
- Excellent written and oral communication skills
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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