Jubilant HollisterStier CMO · 5 hours ago
Sr Specialist, Validation
Spokane, WA
Full-time
Onsite
Senior Level
$92K/yr - $147K/yr
5+ years expJubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Sr. Validation Specialist serves on project teams to ensure critical production equipment meets performance standards and mentors less experienced Validation Associates and Specialists.
Travel
Hiring Manager
Paige Ford
Responsibilities
Leads and executes equipment requalification’s and performance qualifications on critical production equipment and other validation work as needed
Author’s equipment requalification reports to provide documented evidence of equipment requalification’s
Develops program and policy documents for requalification of new equipment. Authors SOPs for requalification of new equipment. Revises validation SOPs to ensure correct and up to date information and processes are followed. Approves SOPs as a department approver
Demonstrates an expert working and theoretical knowledge of the operation of various equipment and systems such as lyophilizers, terminal sterilizers, tanks, autoclaves, dry heat ovens, rinsers, CIP and SIP systems, HVAC, aseptic processing areas, etc
Initiates deviations within the EQMS system. Assist with RCA and authors impact assessments. Completes minor deviations. Authors and approves change controls and CAPAs. Approves deviations as a department approver
Authors validation protocols and reports, developing validation strategies for complex validation projects
Demonstrates an expert knowledge of validation principles and regulatory and industry standards and ensures their application in strategy and approach
Responsible for working interdepartmentally to ensure IQ/OQ/PQ of new equipment is complete
Qualification
Required
BS (hard science) is required
5 years validation experience (3 years with MS) required
Proficiency in standard business computer applications (i.e. Microsoft Outlook, Word, Excel, PowerPoint, etc.) required
Proficiency with EQMS, LMS, and EDMS required
Mastery Technical writing experience required
Functional expert in Mechanical aptitude required
Ability to lift 50 lbs. required
Preferred
Pharmaceutical and FDA regulated industry desired
Working knowledge of Computer System Validation, GAMP Data Integrity, CFR Part 11 desired
Benefits
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
Company
Jubilant HollisterStier CMO
Jubilant HollisterStier (JHS) CMO provides comprehensive sterile fill-finish and lyophilization services, ensuring the consistent delivery of high-quality products that meet the needs of global healthcare markets and patients worldwide.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Chris Preti
Chief Executive Officer
Ian Fuller
Vice President Operations - CMO
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