Senior Validation Engineer – CSV & Data Integrity (Onsite)

Energy Jobline ZR; Bend (OR); On-site; USD 62,000 - 73,000; Part time

Job summary

TekWissen Group is seeking an experienced Senior Specialist and Site DI Lead, Quality Assurance / Senior Validation Engineer to support C&Q and CSV activities in a pharmaceutical/biotech setting. The role emphasizes GxP compliance, data integrity, and keeping validation docs up to date.

You will work with IT, QA, QC, Automation, and vendors to review activities, perform risk assessments, CAPA, and support inspections while driving continuous improvement on site operations.

Qualifications

• Bachelor's degree in science or related field.
• 5+ years in pharma/biotech with at least 2 years in a Quality Unit.
• Experience with equipment/analytical instrument qualification and CSV.

Responsibilities

• Support commissioning, qualification, and computerized system validation projects.
• Prepare, execute, review, and approve validation protocols and reports.
• Collaborate with IT, QC, Automation, QA, and vendors on qualification activities.
• Perform change management and risk assessments.
• Provide SME and ensure consistent validation strategies for equipment and systems.
• Support testing, investigations, and CAPA.
• Participate in client and regulatory inspections.
• Promote Data Integrity and support improvements at the site.
• Lead Data Integrity forums and GEMBA walkthroughs.
• Generate, review, and approve controlled documents.

Skills

Cross-functional collaboration

Troubleshooting

Documentation

Problem-solving

Education

Bachelor's degree in science

Tools

CSV

GxP knowledge

Job description

TekWissen Group is seeking an experienced Senior Specialist and Site DI Lead, Quality Assurance / Senior Validation Engineer to support C&Q and CSV activities in a pharmaceutical/biotech setting. The role emphasizes GxP compliance, data integrity, and keeping validation docs up to date.

You will work with IT, QA, QC, Automation, and vendors to review activities, perform risk assessments, CAPA, and support inspections while driving continuous improvement on site operations.