CSV/CQV Validation Specialist ([email protected])

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: CSV/CQV Validation Specialist

Location: Bend, OR (Onsite)

Duration: 6-9 Month Contract

Pay rate: $93/hr on W2

Schedule: Full-time, onsite

Interview Process: Initial Teams interview followed by a panel interview (Teams or onsite; onsite may be required).

Hiring Manager Notes

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.

Job Description:

Client is seeking a contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with both the Instrumentation and CQV teams.

The successful candidate will split time supporting CQV priorities and the Instrumentation team's CSV activities. This individual must be comfortable managing multiple priorities simultaneously, producing high-quality documentation, and working hands-on with laboratory instruments and equipment in a regulated cGMP environment. Because the position supports physical equipment and instrument qualification activities, onsite presence in Bend, Oregon is required.

Key Responsibilities:

• Develop, execute, review, and maintain validation lifecycle documentation, including:
• Risk Assessments
• 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 escalate 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.

Required Qualifications:

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

Proven experience using 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 equipment qualification versus instrument validation requirements.

Key Competencies:

• 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.