Validation Senior Specialist - Computer Systems

Jubilant Pharma Limited; Spokane (WA); On-site; USD 80,169 - 90,000; Full time

Benefits offered by this job

Medical, Dental & Vision coverage

Flexible Spending Accounts / HealthSav

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant Pharma Limited's Spokane site is seeking a Computerized System Validation Engineer to own CSV activities and ensure data integrity in a on‑site, full‑time role.

You will develop and execute validation plans, write URS and risk assessments, maintain traceability matrices, and prepare qualification protocols for audit readiness across QA, IT, and manufacturing teams.

Qualifications

• Minimum 5 years of related experience with a BS degree (or 10 years without a BS).
• Experience in technical writing and building manufacturing computer control processes.
• QA operation systems and validation experience required.
• GAMP 5 certification strongly preferred.
• Experience with data integrity, computer software validation, GMP record storage and SAP preferred.

Responsibilities

• Perform periodic reviews and audit trail reviews of computerized systems.
• Write and review documents to support qualification of a computerized system.
• Develop and maintain validation plans and test protocols.
• Prepare user requirements specifications and risk assessments.
• Create traceability matrices and qualification protocols and acceptance reports.
• Manage change control documents for computer systems and assist with production changes.
• Write and review CSV SOPs and collaborate with other departments for compliance.
• Support audits, deviations, and investigations related to computerized systems.

Skills

Technical writing

QA operations

Validation experience

GAMP 5 certification

Data integrity

Education

BS degree

Tools

SAP

Job description

Computerized System Validation Engineer

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

• Perform periodic reviews and audit trail reviews of computerized systems.
• Write and review documents to support the qualification of a computerized system.
• Validation plan
• User requirements specifications
• 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.

Qualifications

• Minimum 5 years related experience with a BS degree or 10 years of experience without a BS degree.
• Experience with technical writing, building and manufacturing computer control processes/systems.
• QA operation systems and validation experience is required.
• GAMP 5 certification strongly preferred.
• Experience with data integrity, computer software validation, GMP record storage and SAP preferred.

Location

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 start on day one and include:

• 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

EEO/AA Employer

We are 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.