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Jubilant Pharma Limited · 3 hours ago

Sr Specialist, Validation

Spokane, WA

Full-time

Onsite

Mid, Senior Level

$92K/yr - $147K/yr

5+ years exp

Jubilant 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 in support of complex capital, compliance, and contract projects while demonstrating expert technical validation expertise.

Health CareManufacturingPharmaceutical

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

Validation experienceMechanical aptitudeTechnical writingComputer System ValidationProficiency with EQMSPharmaceutical industry knowledgeMS Office

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 Pharma Limited

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to our customers across geographies.

Founded in 2014

Singapore, Central Region, SGP

1001-5000 employees