Senior Computer Systems Validation Specialist

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 92,000 - 147,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

FSA/HSA

Life & AD&D Insurance

Disability Insurance

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking a Validation Senior Specialist - Computer Systems to lead computerized system validation and data integrity efforts on site. The role includes writing, reviewing, and executing qualification documents and maintaining compliance with 21 CFR and EMA Annex 11.

The position requires a BS or 12 years related experience, with 7–10 years in validation, data integrity, or regulated manufacturing. On-site weekday days with comprehensive benefits.

Qualifications

• Bachelor of Science required, or 12 years relevant Computer System Validation, Data Integrity, Quality Systems, Automation, or regulated pharmaceutical manufacturing experience.
• Minimum 7-10 years related experience with BS degree or 12 years of experience without BS degree.
• Experience with technical writing, building and manufacturing computer control processes/systems.

Responsibilities

• Periodic Reviews and Audit Trail Reviews of computerized systems.
• Write and review documents to support the qualification of a computerized system.
• Create and maintain Validation Plan, User Requirements Specification, Risk Assessment, Traceability Matrix, Qualification Protocol, Test Plan, and Acceptance Reports.
• Write and manage change control documents for computerized systems and assist with change controls for production systems.
• Write and review CSV SOPs and partner with other departments to ensure site compliance.

Skills

Technical writing

CSV validation

Automation

Data integrity

Education

Bachelor of Science or equivalent

12 years relevant experience without BS

Tools

SAP

GAMP 5

Job description

Jubilant HollisterStier LLC in Spokane, WA is seeking a Validation Senior Specialist - Computer Systems to lead computerized system validation and data integrity efforts on site. The role includes writing, reviewing, and executing qualification documents and maintaining compliance with 21 CFR and EMA Annex 11.

The position requires a BS or 12 years related experience, with 7–10 years in validation, data integrity, or regulated manufacturing. On-site weekday days with comprehensive benefits.