
Validation Specialist Position
3 days ago
We are seeking a skilled professional to develop and implement computer validation strategies, plans, protocols, and reports for new or changed validation systems.
The ideal candidate will have a strong understanding of automation systems, such as Siemens PCS7 and DeltaV, as well as knowledge of GAMP5, ANSI/ISA-88, and 21 CFR Part 11 requirements.
- Develop and implement computer validation strategies, plans, protocols, and reports for new or changed validation systems.
- Ensure regulatory compliance based on risk assessment.
- Review and approve validation protocols, reports, and deliverables for specialized validation areas.
- Define requirements for validation activities and ensure regulatory compliance based on risk assessment.
- Creation and/or review of validation lifecycle documents, including user requirement specification, functional specification, risk assessments, validation protocols, and reports.
- Degree in Engineering, Pharmaceutical, or Computer Science or related studies.
- At least 3 years of experience in a CSV role within the pharmaceutical industry.
- Good fundamental technical knowledge of automation systems, such as Siemens PCS7 and DeltaV, to assist automation engineers in developing life cycle documentation.
- Knowledgeable in GAMP5, ANSI/ISA-88, and 21 CFR Part 11 requirements.
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