Validation Specialist

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.