Validation Engineer 2

Tailored Management; Bend (OR); Vor Ort; USD 148.000 - 207.000; Vollzeit

Benefits dieser Stelle

Weekly Pay

Medical Insurance

Dental Insurance

Vision Insurance

Zusammenfassung

Creative Solutions Services, LLC is seeking a Validation Engineer 2 – CSV/CQV Specialist to support a high-priority backlog of qualification activities onsite in Bend, OR. This role emphasizes validation of analytical instruments, computerized systems, and GMP equipment, partnering with Instrumentation and CQV teams.

The ideal candidate has 3–5+ years of CSV/CQV experience in regulated settings, strong technical writing skills, and the ability to manage competing priorities while delivering

Qualifikationen

• 3–5+ years of CQV and/or CSV experience in regulated industries.
• Experience validating analytical laboratory instruments and equipment.
• Experience in a cGMP-regulated environment with computerized systems validation.

Aufgaben

• Develop, execute, review, and maintain validation lifecycle documentation.
• Support qualification of analytical instruments and GMP equipment.
• Execute IQ/OQ/PQ activities and validation execution.
• Ensure data integrity and compliance with 21 CFR Part 11 and EU Annex 11.
• Collaborate with QC, Instrumentation, Engineering, QA on validation plans.
• Utilize Kneat for document creation, routing, approvals, and closures.

Kenntnisse

CSV/CQV experience

Analytical lab exp

Technical writing

Project management

Cross-functional teamwork

Ausbildung

Bachelor's degree in Engineering/Life Sciences

Tools

Kneat

Jobbeschreibung

Validation Engineer 2 – CSV/CQV Specialist

Location: 1201 NW Wall Street, Bend, OR 97703
Work Model: Full-Time, Onsite
Contract Duration: 6–9 Months (Potential for Extension or Full-Time Conversion)
Pay Rate: $70.92–$99.29/hour (W2)
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance

Position Overview

Our client is seeking a Contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV organization. This role will focus on the validation of analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with the Instrumentation and CQV teams.
The ideal candidate will have strong CSV and CQV experience, preferably within an analytical laboratory or pharmaceutical/biotechnology environment. This position requires someone who can effectively manage competing priorities, produce high-quality validation documentation, and participate in hands‑on qualification and field execution activities.
Onsite presence in Bend, Oregon is required.

Hiring Manager Priorities

• Immediate need due to a significant CQV validation backlog.
• Strong preference for candidates with analytical laboratory experience.
• Candidates with both CSV and CQV experience are highly preferred.
• Must be comfortable balancing priorities between CQV and Instrumentation teams.
• Must be willing to work onsite in Bend to support instrument qualification and field execution activities.
• Previous experience with backlog remediation or high-volume validation activities is highly desirable.

Key Responsibilities

• Develop, execute, review, and maintain validation lifecycle documentation, including:
  • Risk Assessments
  • User Requirements 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 EU 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 the Kneat validation platform for 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, drive discrepancy resolution, and elevate issues as needed.
• Provide support to the Instrumentation team for CSV activities and the CQV team for qualification execution, documentation updates, and readiness activities.
• Travel between Bend campus buildings as needed to support laboratory instrument and equipment qualification.
• Perform other duties as assigned.

Required Qualifications

Education

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

Experience

• 3–5+ years of CQV and/or CSV experience within pharmaceutical, biotechnology, medical device, or another regulated industry.
• Experience supporting qualification of analytical laboratory instruments and equipment.
• Experience working in a cGMP-regulated environment.
• Experience with computerized systems validation and equipment qualification.
• Experience managing multiple validation projects and competing priorities.
• Experience supporting validation backlogs or high-volume validation activities is highly desirable.

Technical Knowledge

• Hands‑on experience with Kneat validation/documentation software.
• 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 the differences between equipment qualification and instrument/computerized system validation.

Key Competencies

• Excellent technical writing and documentation skills.
• Strong organizational skills and attention to detail.
• Ability to prioritize multiple projects and stakeholder requirements.
• Strong analytical and problem‑solving skills.
• Ability to work independently and collaboratively in a regulated environment.
• Strong communication and cross‑functional collaboration skills.
• Commitment to quality, compliance, and data integrity.
• Ability to work effectively in a fast‑paced environment with a significant validation backlog.

Physical & Environmental Requirements

• Work within a clean, secure, and regulated GMP environment.
• Follow all required site safety procedures and wear appropriate PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.
• Ability to occasionally lift up to 50 pounds.
• Ability to travel between site buildings as needed.
• Flexibility to support project and field execution activities.

Ideal Candidate Profile

The strongest candidate will be an experienced CSV/CQV professional with analytical laboratory instrument qualification experience, strong GMP documentation skills, and hands‑on experience executing IQ/OQ/PQ activities. Candidates who have worked with Kneat, supported validation backlogs, and can effectively balance CSV responsibilities with CQV execution will be highly competitive.
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