Senior Validation Engineer - CSV & Data Integrity

TekWissen ®; Bend (OR); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

TekWissen is seeking an experienced Senior Specialist and Site DI Lead, Quality Assurance / Senior Validation Engineer to support commissioning and qualification (C&Q) and Computerized System Validation (CSV) activities within a pharmaceutical / biotechnology environment.

The role focuses on ensuring compliance with GxP requirements, applicable regulations, and industry standards while promoting Data Integrity (DI), maintaining validation documentation, supporting inspections, and driving

Qualifications

• Bachelor's degree in science or related field.
• Minimum of five years in pharma/biotech with at least two in a Quality Unit.
• Experience in equipment and analytical instrument qualification.
• Experience with computerized systems validation (CSV).
• Working knowledge of GxP requirements and relevant standards.

Responsabilités

• Support commissioning, qualification, and computerized system validation projects.
• Prepare, execute, review, and approve validation protocols, reports, and lifecycle docs.
• Collaborate with IT, QC, Automation, QA, and vendors to review activities.
• Perform change management and risk assessments.
• Provide SME input and ensure consistent validation strategies for systems and methods.
• Support troubleshooting, investigations, CAPA, and training.
• Participate in client and regulatory inspections.
• Promote Data Integrity and drive site DI maturity improvements.

Connaissances

Data Integrity

Validation

GxP Knowledge

Regulatory Compliance

Cross-functional

Documentation

CAPA

Problem Solving

Formation

Bachelor's degree in science

Outils

CSV

Description du poste

TekWissen is seeking an experienced Senior Specialist and Site DI Lead, Quality Assurance / Senior Validation Engineer to support commissioning and qualification (C&Q) and Computerized System Validation (CSV) activities within a pharmaceutical / biotechnology environment.

The role focuses on ensuring compliance with GxP requirements, applicable regulations, and industry standards while promoting Data Integrity (DI), maintaining validation documentation, supporting inspections, and driving