Validation Specialist
Intellectt INC
Job Title : CSV/CQV Validation Specialist
Location : Oregon 100% Onsite
Duration : Contract
Job Summary:
Seeking a CSV/CQV Validation Specialist to support validation and qualification activities for analytical laboratory instruments, computerized systems, and GMP equipment in a cGMP biopharmaceutical environment.
Job Requirements:
- 3 5 years of CSV/CQV experience in Pharma/Biotech or regulated industries.
- Hands-on IQ/OQ/PQ and laboratory instrument qualification experience.
- Strong knowledge of cGMP, GxP, 21 CFR Part 11, EU Annex 11, and Annex 15.
- Experience with validation documentation and platforms such as Kneat.
- Experience with deviations, CAPAs, change controls, and validation protocols.
- Strong documentation, communication, and organizational skills.
- Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or related field preferred.
- Must be available to work onsite in Oregon.
Vacancy posted 3 days ago
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