Ensure compliance with 21 CFR Part 11 and data integrity verification.
Collaborate with cross-functional teams to plan and execute validation activities.
Utilize the Kneat platform for documentation and workflow processes.
Monitor field execution activities and address discrepancies promptly.
Benefits
Opportunity to work in a high-priority, dynamic environment.
Collaboration with cross-functional teams including Quality Control and Engineering.
Hands-on experience with cutting-edge laboratory equipment.
Potential for involvement in continuous improvement initiatives.
Onsite presence allows for direct engagement with projects.
Full Job Description
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 Dawn Bosco's 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.
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.
ssist 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.
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.
nnex 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.
bility to prioritize effectively across multiple projects and stakeholders.
Proactive problem-solving skills.
bility 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.
