Validation Specialist - Computer Systems

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

Benefits offered by this job

Medical/Dental/Vision

FSA/HSA

Life/AD&D

Disability Insurance

Job summary

Jubilant HollisterStier Spokane is seeking a Validation Senior Specialist - Computer Systems to lead validation activities for computerized systems and maintain data integrity at the Spokane site. The role covers periodic reviews, audit trails, and qualification documentation in a regulated pharmaceutical environment.

You will draft and review validation plans, URS, risk assessments, and traceability matrices, ensuring compliance with 21 CFR and EMA Annex 11.

Qualifications

• useful background in computer system validation and data integrity within regulated pharm manufacturing.
• experience with building and maintaining CSV documents and validation protocols.
• familiarity with 21 CFR Part 11 and EMA Annex 11 requirements.

Responsibilities

• Perform Periodic Reviews and Audit Trail Reviews of computerized systems.
• Write and review documents to support the qualification of a computerized system.
• Prepare and manage Validation Plans, User Requirements Specifications, Risk Assessments, and Traceability Matrices.
• Develop and review Qualification Protocols, Test Plans and Acceptance Reports.
• Create and maintain Change Control documentation for production computerized systems.

Skills

Data Integrity

Technical Writing

Automation

Quality Systems

Regulatory Compliance

GAMP 5

SAP

Education

Bachelor of Science

Tools

SAP

Job description

Validation Senior Specialist - Computer Systems

Jubilant HollisterStier 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 click here. If you’d like more information on your EEO rights under the law, please click here.

JOB DESCRIPTION

Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next

As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging 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 HollisterStier 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 lifechanging medicines around the world.

For the Builders, Innovators, and Doers — This Is Your Place

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

Why builders choose us:

• 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.

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

Required:

• 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.

Preferred:

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

Location: Spokane, WA — On Site, Full- -Time

Shift: Weekday Days

Compensation & Benefits That Start on Day One — Because Your Well Being Matters

Hiring Wage: $91,950 - $147,100/year , with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

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

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.

Our Promise: Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.

COMPANY :

Jubilant HollisterStier Spokane