Tech Services Specialist I / II / Sr. _L4

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 position of Technical Services Specialist I/II/Sr. has responsibility for one or more of the following areas within Technical Services: technical transfer of new products from both internal and external clients; manufacturing support for process and material investigations or media fill program coordination. The Specialist performs tasks within these areas, without direct supervisory responsibilities.

This position may be in one or more areas within Technical Services. Each position may not have each of the following responsibilities; however, each position will have some of these responsibilities. Position may be at-location or hybrid (at-location/remote work).

1. Evaluate incoming processes for robustness, efficiency and fit within JHS-Spokane. Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing. Author validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product.

2. Represent Technical Services on Project Teams for internal and external projects.

3. Perform investigations for process and material deviations, driving to root cause. Implement effective CAPAs designed to empower flawless execution.

4. Provide support to all departments associated with manufacturing processes: Manufacturing, Technical Writing and Microbiological Quality Control (MQC).

5. Ensure that all applicable U.S. and European regulatory requirements are being met within Technical Services' owned procedures and practices.

6. Review data summaries generated by other departments, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted.

7. Provide necessary summaries and reviews for regulatory and customer inspectors/auditors; provide responses to written observations made by the inspector/auditors, and ensure that all corrective action measures are completed as described and within the time-frame given in the response.

8. Review assigned Standard Operating Procedures (SOP's), Protocols and Acceptance Reports from the perspective of scientific soundness and compliance with applicable regulatory requirements, and provide input/changes as needed.

9. Ensure that investigations related to deviations are complete and adequate

10. Troubleshooting, oversight and/or sampling of events within Manufacturing will require occasional off-shift at-location support.

Specialist II in addition to above:

• Advise other Specialists within Technology Transfer, Manufacturing Support or Media Fills.

Sr. Specialist in addition to above:

• Mentor Specialists within Technology Transfer, Manufacturing Support or Media Fills

Qualifications:

Specialist I:

• A Bachelor's degree in Biology, Chemistry, Physics, or engineering is required.
• Pharmaceutical experience and FDA regulated Industry Experience is desired.
• Microsoft Word, Microsoft Excel, PowerPoint, Microsoft Outlook.
• This position requires an in-depth understanding of cGMP's, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and dehydrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.

Specialist II in addition to above:

• Minimum of 2 to years of combined experience within pharmaceutical and/or FDA industry experiences

Sr. Specialist in addition to above

• Minimum of 5 to 10 years of combined experience within pharmaceutical and/or FDA industry experiences. Master's Degree counts as 2 yrs. of experience
• Master's degree preferred.

Shift: Weekdays

Compensation & Benefits:

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

• Hiring Wage:
  • Specialist I: $77,968.80 - $83,700
  • Specialist II: $77,968.80 - $98,500
  • Sr. Specialist: $77,968.80 - 115,800 annually depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.

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

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

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:

Human.Resources@jubl.com