Validation Engineer 2

Contractor, CSV/CQV SpecialistLocation: Bend, OR (Onsite)Duration: 6-9 Month ContractSchedule: Full-time, onsiteInterview Process: Initial Teams interview followed by a panel interview (Teams or onsite; onsite may be required).Hiring Manager NotesImmediate 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.Position SummaryLonza 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.Key ResponsibilitiesDevelop, execute, review, and maintain validation lifecycle documentation, including:Risk AssessmentsUser Requirement Specifications (URS)Design SpecificationsTraceability MatricesTest ScriptsValidation ProtocolsDiscrepancies and DeviationsSummary ReportsPeriodic Review DocumentationSystem Retirement DocumentationSupport 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 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 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 QualificationsEducation: 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 working in cGMP-regulated environments.Experience with computerized systems validation and equipment managing multiple validation projects and competing priorities.Previous backlog remediation or high-volume validation support experience is highly desirable.Technical KnowledgeProven experience using Kneat validation/documentation software.Strong understanding of GMP documentation requirements and validation practices.Knowledge of:GxP regulations21 CFR Part 1121 CFR Parts 210 and 211EU Annex 11Annex 15USP and ASTM standardsUnderstanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.Strong understanding of equipment qualification versus instrument validation requirements.Key CompetenciesExcellent 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 RequirementsWork 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.Job Summary: CQV Validation Specialist Shift: ['cGMP Guidelines', 'Computer System Validation (CSV)', 'CQV']EEO: \"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.\"