Validation & Data Integrity Specialist

Katalyst-Healthcares-; Bend (OR); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

Katalyst-Healthcares- seeks a qualified validation specialist to support equipment qualification, analytical instrument qualification, and computerized systems validation, ensuring GxP and 21 CFR Part 11 compliance. The role leads Data Integrity initiatives, drives DI maturity, and collaborates with IT, QC, Automation, QA, and vendors.

The ideal candidate has 5+ years in pharma/biotech, 2+ years in a Quality Unit, and hands-on experience with validation lifecycle documents and DI programs.

Qualifications

• 5+ years in pharmaceutical/biotech or related industry.
• 2+ years in a Quality Unit.
• Experience with equipment and analytical instrument qualification.
• Experience with computerized systems validation.
• Working knowledge of GxPs, 21 CFR Part 11, Annex 11 and USP standards.

Responsibilities

• Support commissioning, qualification and computer system validation projects.
• Write, execute, review and approve validation protocols and reports.
• Collaborate with IT, QC, Automation, QA, and vendors for qualification activities.
• Perform change assessments and risk assessments.
• Act as SME for validation strategy for equipment, systems, computers, and methods.
• Troubleshoot systems and support staff training.
• Participate in client and regulatory inspections.
• Assist with investigations, root cause analysis, and CAPAs.
• Promote Data Integrity culture and raise DI awareness site-wide.
• Generate, review, and approve controlled documents and records.

Skills

Data Integrity

Validation strategy

GxPs knowledge

Process troubleshooting

Stakeholder collaboration

Education

Bachelor's degree in Science

Job description

Katalyst-Healthcares- seeks a qualified validation specialist to support equipment qualification, analytical instrument qualification, and computerized systems validation, ensuring GxP and 21 CFR Part 11 compliance. The role leads Data Integrity initiatives, drives DI maturity, and collaborates with IT, QC, Automation, QA, and vendors.

The ideal candidate has 5+ years in pharma/biotech, 2+ years in a Quality Unit, and hands-on experience with validation lifecycle documents and DI programs.