Validation Engineer II

TekWissen•Bend, OR

4d•Onsite

About The Position

Support 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 the Instrumentation and CQV teams. The successful candidate will split time supporting CQV priorities and Instrumentation team CSV activities, manage multiple priorities simultaneously, produce high-quality documentation, and work hands-on with laboratory instruments and equipment in a regulated cGMP environment. Onsite presence is required.

Requirements

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

Nice To Haves

Previous backlog remediation or high-volume validation support experience is highly desirable.

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, and 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 campus buildings as needed to support laboratory instrument and equipment qualification activities.
Perform other duties as assigned.