CSV Engineer
Katalyst Healthcares and Life Sciences
Job Description:
- Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment.
- The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require.
- Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.
- Candidates should be comfortable supporting multiple validation workstreams and working independently in a fast-moving project environment.
- pproximately 5-10 years of validation experience within pharmaceutical, biotechnology, biopharmaceutical, or another GMP-regulated environment.
- Strong Computer System Validation experience.
- Experience supporting validation of GMP computerized systems.
- Working knowledge of the CSV lifecycle, including validation planning, requirements, risk assessment, testing/protocol execution, traceability, and validation documentation.
- Understanding of data integrity and GMP expectations for computerized systems.
- Equipment validation / CQV experience in addition to CSV.
- bility to execute established validation protocols and clearly document results.
- Experience investigating and documenting validation discrepancies or execution issues.
- bility to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
- ValGensis is a plus.
Vacancy posted more than 2 months ago
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