Senior Validation Engineer

TekWissen • Bend, OR

2d • Onsite

About The Position

TekWissen is recruiting a Senior Validation Engineer for an onsite, 12-month temporary assignment in Bend, Oregon. The position supports commissioning and qualification (C&Q) and Computerized System Validation (CSV) activities in a pharmaceutical or biotechnology environment. It focuses on compliance with GxP requirements, applicable regulations, and industry standards; promoting Data Integrity (DI); maintaining validation documentation; supporting inspections; and advancing continuous improvement across site operations. The role is also described as Senior Specialist and Site DI Lead, Quality Assurance.

Requirements

• Bachelor's degree in Science or a related discipline.
• At least five years of experience in the pharmaceutical, biotechnology, or related industry, including at least two years in a Quality Unit.
• Experience in equipment and analytical instrument qualification.
• Experience with computerized systems validation (CSV).
• Working knowledge of GxP requirements, 21 CFR Part 11, EU GMP Annex 11, and relevant industry standards such as USP.
• Knowledge of commissioning, qualification, and validation processes, including validation documentation and system lifecycle management.
• Understanding of change management, risk assessments, Data Integrity principles, investigations, root cause analysis, and CAPA.
• Strong cross-functional collaboration, technical troubleshooting, documentation, and problem-solving skills.
• Ability to support regulatory inspections, validation oversight, and continuous improvement initiatives.
• Ability to wear personal protective equipment (PPE), perform occasional light lifting of less than 25 lbs, and travel as needed.

Responsibilities

• Support commissioning, qualification, and computerized system validation projects.
• Prepare, execute, review, and approve validation protocols, reports, and system lifecycle documentation.
• Collaborate with IT, Quality Control (QC), Automation, Quality Assurance (QA), and vendors to review and approve qualification and validation activities.
• Perform change management and risk assessments.
• Provide subject matter expertise and ensure consistent validation strategies for equipment, systems, computerized systems, and methods.
• Support system troubleshooting, staff training, investigations, root cause analysis, and corrective and preventive actions (CAPA).
• Participate in client and regulatory inspections.
• Promote Data Integrity awareness and support improvements in site Data Integrity maturity.
• Establish and facilitate Data Integrity forums to share best practices, review remediation activities, discuss training, and address potential Data Integrity risks.
• Conduct regular Data Integrity GEMBA walkthroughs.
• Generate, review, and approve controlled documents and records.
• Oversee validation activities, support problem resolution, and make decisions related to commissioning, qualification, and validation.
• Collaborate with stakeholders to resolve findings and reduce potential Data Integrity risks identified through assessments and gap analyses.

What This Job Offers

• Career Level: Senior