Validation Engineer

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 an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

Job Title: Contractor, CSV/CQV Specialist

Duration: 09 Month Contract (Extendable)

Pay Rate range: $90.00 - 97.00/hr on W2

• Immediate need due to a significant CQV validation backlog.
• Strong preference for candidates with analytical laboratory experience.
• Must be comfortable balancing priorities between CQV and Instrumentation teams.
• Onsite presence in Bend is required to support instrument qualification and field execution activities.
• Candidates with both CSV and CQV experience will be highly preferred.

Key Responsibilities

• Develop, execute, review, and maintain validation lifecycle documentation, including:
• User Requirement Specifications (URS)
• Design Specifications
• Traceability Matrices
• Test Scripts
• Validation Protocols
• Discrepancies and Deviations
• Summary Reports
• Periodic Review Documentation
• System Retirement Documentation
• Support qualification and validation activities for new and existing analytical laboratory instruments, computerized systems, and GMP equipment.
• Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Ensure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and Annex 11 requirements.
• Partner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation activities.
• Prepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols related to GMP equipment, analytical instruments, and computerized systems.
• Utilize and support the Kneat validation platform, including document creation, workflow routing, approvals, and record closure.
• Assist with Kneat template development and continuous improvement initiatives.
• Maintain inspection-ready documentation in accordance with SOPs, GxP requirements, and site procedures.
• Monitor field execution activities, identify gaps early, drive discrepancy resolution, and elevate issues as appropriate.
• Split support between the Instrumentation team for CSV activities and the CQV group for qualification execution, documentation updates, and readiness activities.
• Travel between Bend campus buildings as needed to support laboratory instrument and equipment qualification activities.
• Perform other duties as assigned.

Education:

Bachelor's Degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.

Experience

• Minimum 3-5 years of CQV and/or CSV experience within pharmaceutical, biotechnology, or other regulated industries.
• Experience supporting analytical laboratory instruments and equipment qualification.
• Experience working in cGMP-regulated environments.
• Experience with computerized systems validation and equipment qualification.
• Experience managing multiple validation projects and competing priorities.
• Previous backlog remediation or high-volume validation support experience is highly desirable.

Technical Knowledge

• Strong understanding of GMP documentation requirements and validation practices.
• Knowledge of:
• GxP regulations
• 21 CFR Part 11
• 21 CFR Parts 210 and 211
• EU Annex 11
• Annex 15
• USP and ASTM standards
• Understanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.
• Strong understanding of equipment qualification versus instrument validation requirements.
• Excellent technical writing and documentation skills.
• Strong organization and attention to detail.
• Ability to prioritize effectively across multiple projects and stakeholders.
• Proactive problem-solving skills.
• Ability to work both independently and collaboratively in a regulated environment.
• Strong communication and cross-functional collaboration skills.
• Commitment to quality, compliance, and data integrity.

Physical & Environmental Requirements

• Work within a clean, secure, and regulated GMP environment.
• Wear required PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.
• Occasional lifting of up to 50 pounds.
• Travel between site buildings as needed.
• Flexible schedule to support project activities.