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Computer Systems Validation Specialist
1 month ago
We are seeking a skilled Computer Systems Validation Engineer to join our team in Australia. The successful candidate will be responsible for developing and executing protocols and test scripts, identifying gaps, and consulting on and directing plans for resolution.
The ideal candidate will have a strong background in computer systems validation, with experience in GxP environments and a deep understanding of 21 CFR Part 11. They will be able to analyze results and determine the acceptability of results against predetermined criteria.
Key Responsibilities:- Develop and execute protocols and test scripts
- Identify gaps and consult on and direct plans for resolution
- Analyze results and determine the acceptability of results against predetermined criteria
- Investigate and troubleshoot problems
- Coordinate with other departments or outside contractors/vendors to complete validation tasks
- Participate in regulatory audits and communicate company's computer validation policies
- BS in a Computer Science or Engineering field or equivalent experience
- Minimum 2-7 years' experience with Computer systems validation
- Minimum 2-7 years' experience working in a GMP environment
- Experience in Data Integrity with GAMP and 483, compliance, deep 21 CFR Part 11 experience highly desired
- Experience in biotech and pharma is preferred over medical device
- Highly Competitive Salary
- Continuing education (internal and external)
- Opportunities to work on cutting edge projects in a highly evolving field
