Validation Associate

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. 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 Validation Associate works closely with the Validation Specialist in support of capital, contract, and compliance projects. This position is responsible for executing a variety of validation studies, including performance qualifications and/or requalifications for terminal and component sterilization work. Additionally, the Validation Associate will:

1. Assist with writing and executing applicable validation protocols associated with the given project.
2. Author relevant acceptance reports for the respective protocols.
3. Provide timely and accurate updates to the respective project leader / project team with regard to validation activities.
4. Once validation effort(s) are complete for given equipment or process, ensure applicable SOP(s) are updated and reflect results stated in approved acceptance report(s).
5. Provide validation support to project teams involved in facility and utility expansion, compliance upgrades, cost reduction, contract manufacturing, process improvements, construction projects, etc
6. Through education and experience possess a working knowledge of the operation of equipment and systems. This includes, but is not limited to, equipment and systems such as mix tanks, autoclaves, dry heat ovens, vial and stopper rinsers, CIP and SIP systems, HVAC systems, aseptic processing areas, etc.
7. Utilize excellent communication skills, including the ability to organize and write detailed protocols and reports. This includes the ability to use Good Documentation Practices to document the validation of systems and equipment
8. Properly apply knowledge of current industry practices and CGMP requirements with regard to the validation of equipment and systems
9. Possess the interpersonal skills necessary to work with project team members from various disciplines. This includes Manufacturing, Quality Assurance, Regulatory Affairs, Engineering/Maintenance, and Technical Services.
10. Work closely with user departments to schedule validation tasks in a manner which maximizes the efficiencies of the study, while having minimal impact on the routine operations of the user department.
11. Validation Associate may be required to execute validation work on production equipment during non-production times. This may result in a need to flex work times to cover evenings or weekends on occasion.
12. Other duties as assigned.

Qualifications:

• Associates of Science in technical or scientific discipline required, OR 3 years related experience in lieu of degree. Bachelors of Science desired.
• Minimum 6 months of related experience required. 1-2 years experience in a regulated industry desired.
• Pharmaceutical and FDA Regulated industry experience desired.
• Validation experience desired.
• Working knowledge of Microsoft Word and Excel required.
• Ability to lift 40 lbs unassisted.

Shift: Day

Compensation:

• The salary range for this position is $67,725 - $100,300 depending on experience.

Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibits outstanding performance over a period of time in the role

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

Optional Benefits:

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount Program

Jubilant HollisterStier is a great place to grow!
If you're up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jublhs.com/careers/career-opportunities
*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 their protected veteran status and will not be discriminated against on the basis of disability.

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

HResources@jhs.jubl.com