Sr Specialist, Validation
About The Position
Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. 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 Sr. Validation Specialist serves on project teams in support of complex capital, compliance, and contract projects while demonstrating expert technical validation expertise. The Sr. Validation Specialist also leads and assists in the execution and documentation of validation work to ensure critical production equipment meets satisfactory performance standards. The Sr. Validation Specialist also mentors less experienced Validation Associates and Specialists.
Requirements
- 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
Nice To Haves
- Pharmaceutical and FDA regulated industry desired
- Working knowledge of Computer System Validation, GAMP Data Integrity, CFR Part 11 desired
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
