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.
Pay ranges between 85-93/hr based on experience
