Contract CSV/CQV Validation Specialist

Net2Source (N2S); Bend (OR); On-site; USD 124,000 - 134,000; Full time

Job summary

Net2Source Inc. is seeking a Contractor, CSV/CQV Specialist to join the Bend, OR assignment. This 9-month contract requires onsite work supporting CQV and CSV activities for analytical laboratory instruments and GMP equipment.

The role emphasizes strong project management, regulatory knowledge (21 CFR Part 11, EU Annex 11), and collaboration with Quality, Instrumentation, and Engineering teams to ensure timely validation deliverables.

Qualifications

• 3–5 years of CQV and/or CSV in regulated industries.
• Experience with analytical laboratory instruments qualification.
• Experience with computerized systems validation and GMP equipment.

Responsibilities

• Develop, execute, review, and maintain validation lifecycle docs (URS, DS, TM, test scripts, protocols).
• Support IQ/OQ/PQ activities for analytical instruments and GMP equipment.
• Ensure data integrity and 21 CFR Part 11 compliance.
• Collaborate with Quality, Instrumentation, and Engineering teams to plan validation activities.
• Prepare change controls, deviations, CAPAs, and validation documentation.
• Travel between Bend campus buildings to support onsite qualification.

Skills

CQV

CSV

Validation

GMP

Documentation

Data Integrity

Education

Bachelor's Degree in Engineering

Tools

Kneat Validation

Job description

Net2Source Inc. is seeking a Contractor, CSV/CQV Specialist to join the Bend, OR assignment. This 9-month contract requires onsite work supporting CQV and CSV activities for analytical laboratory instruments and GMP equipment.

The role emphasizes strong project management, regulatory knowledge (21 CFR Part 11, EU Annex 11), and collaboration with Quality, Instrumentation, and Engineering teams to ensure timely validation deliverables.