Computer System Validation Specialist

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

The Computer SystemValidation Specialist is responsible for the computerized system validation and data integrity at the JHS-Spokane site. The job functions include periodic, user access, 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.

• Perform Periodic User Access and Audit Trail Reviews of computerized systems.
• Write and review documents to support the qualification of a computerized system:
  • 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 IT systems and assist with changing 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.
• Experience with Data Integrity, Computer Software Validation, GMP records storage and SAP preferred.

Qualifications:

• Bachelor of Science required with minimum 5 years related experience, or 10 years relevant experience required in lieu or BS degree.
• Experience with technical writing, building and manufacturing computer control processes/systems.
• QA operation systems and validation is required.
• Experience with Data Integrity, Computer Software Validation, GMP records storage and SAP preferred.

Shift: Weekdays

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• Hiring Wage: $77,968.80 - 104,500 annually depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.

Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Optional Benefits:

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount Program

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you require assistance applying for a position, please contact our HR Department at:

Human.Resources@jubl.com