Validation Senior Specialist - Computer Systems

Jubilant HollisterStier LLC; Spokane (WA); On-site; USD 80,469 - 90,000; Full time

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking a seasoned professional to oversee computerized system validation and data integrity at the JHS-Spokane site. You will conduct periodic reviews, author qualification documents, and manage change control for production systems, ensuring compliance during audits.

Candidates should have 5+ years of relevant experience with a BS degree (or 10+ years without one) and strong writing, validation, and QA background.

Qualifications

• Minimum 5 years related experience with BS degree or 10 years of experience without BS degree.
• Experience with technical writing, building and manufacturing computer control processes/systems.
• QA operation systems and validation experience required.
• GAMP 5 Certification strongly preferred.
• Experience with Data Integrity, Computer Software Validation, GMP records storage and SAP preferred.

Responsibilities

• Perform periodic reviews and audit trail reviews of computerized systems.
• Write and review documents to support the qualification of a computerized system, including: Validation Plan, User Requirements Specification, Risk Assessment, Traceability Matrix, Qualification Protocol, Qualification Test Plan, Qualification Acceptance Report, Validation Plan Acceptance Report.
• Write and manage change control documents for computerized systems and assist with change controls for production computerized systems as necessary.
• Write and review CSV SOPs.
• Partner with other departments to ensure the site is compliant.
• Provide support for computerized systems during audits, deviations, and investigations.

Skills

Technical writing

Data integrity

Validation

GAMP 5

Education

BS degree

Tools

SAP

Job description

Job Description

Responsible for the computerized system validation and data integrity at the JHS-Spokane site. The job functions include periodic review and audit trail reviews. Drafting, reviewing, and executing equipment-specific test plans. Drafting and reviewing user requirement specifications, risk assessments, traceability matrix, and qualification protocols - including test plans and acceptance reports.

Responsibilities

1. Perform periodic reviews and audit trail reviews of computerized systems.
2. Write and review documents to support the qualification of a computerized system, including:
   1. Validation Plan
   2. User Requirements Specification
   3. Risk Assessment
   4. Traceability Matrix
   5. Qualification Protocol
   6. Qualification Test Plan
   7. Qualification Acceptance Report
   8. Validation Plan Acceptance Report
3. Write and manage change control documents for computerized systems and assist with change controls for production computerized systems as necessary.
4. Write and review CSV SOPs.
5. Partner with other departments to ensure the site is compliant.
6. Provide support for computerized systems during audits, deviations, and investigations.

Qualifications

• Minimum 5 years related experience with BS degree or 10 years of experience without BS degree.
• Experience with technical writing, building and manufacturing computer control processes/systems.
• QA operation systems and validation experience required.
• GAMP 5 Certification strongly preferred.
• Experience with Data Integrity, Computer Software Validation, GMP records storage and SAP preferred.

Location and Shift

Spokane, WA - On Site, Full-Time

Shift: Mon-Fri, 8am-5pm

Compensation & Benefits

Hiring Wage: $80,169.00 - $90,000.00, with opportunities for growth, promotion, and annual raises.

Benefits begin on day one:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Equal Employment Opportunity

Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require assistance applying, contact [e-mail]