Sr Specialist, Validation

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.

• 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.

Qualifications:

• BS (hard science) is required
• 5 years validation experience (3 years with MS) required
• Pharmaceutical and FDA regulated industry desired
• Working knowledge of Computer System Validation, GAMP Data Integrity, CFR Part 11 desired
• 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

Shift: Weekday Days, Monday-Friday

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• Hiring Wage: $91,950 - $147,100 annually depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role
• 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

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All 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.

If you require assistance applying for a position, please contact our HR Department at:

JHS-TalentAcquisition@jubl.com