Validation Specialist - Computer Systems

Validation Senior Specialist - Computer Systems

Jubilant Hollister Stier Spokane is an equal opportunity employer. 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.
For our EEO Policy Statement, please . If you’d like more information on your EEO rights under the law, please .

As Spokane’s Largest Manufacturing Company
, Jubilant Hollister Stier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life changing medicines around the world.
We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant Hollister Stier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life changing medicines around the world.

If you are someone who thrives on solving complex problems, improving systems, and building real solutions
, you’ll feel at home here. At Jubilant Hollister Stier, your ideas matter — and your impact is felt globally.

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn’t have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas —
you belong here.

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. This person ensures the site’s data integrity strategy is sound and incoming systems are appropriately qualified and requalified to meet 21

CFR and EMA Annex 11 requirements.

• 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 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 and data integrity strategy during audits, deviations, and investigations.

• Bachelor of Science required, or 12 years relevant Computer System Validation, Data Integrity, Quality Systems, Automation, or regulated pharmaceutical manufacturing experience may be considered.
• 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.

• GAMP 5 Certification
• Experience with Data Integrity, Computer Software Validation, GMP records storage and SAP preferred.