Sr. Engineering Compliance Specialist

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.

Primary responsibilities include:

The Sr. Engineering Compliance Specialist is responsible for collaboration and leadership with multi-disciplinary teams to scope, solution, and drive resolution for compliance issues. The Specialist helps drive the Department (Engineering, Maintenance, Validation) goal that all manufacturing equipment, processes, and documentation meet regulatory standards and demonstrate suitability.

• Maintain site compliance in JHS documentation systems (BM-RAM, SAP, Trackwise, etc.). The Sr. Specialist will be assigned identified gaps, generally output from Client, Internal, or Regulatory Body audits, Deviation CAPAs, etc.. The Sr. Specialist will drive resolution to these gaps to ensure JHS can demonstrate an appropriate state of control and compliance for all equipment, systems, facilities, and utilities.
• Provides direction and instruction to both professional and non-degreed department staff members and is responsible for motivating, tracking, and evaluating their work.
• May be asked to participate in audits, which requires extensive contact with clients and members of regulatory agencies.
• Ensuring with facility complies with cGMPs and regulatory guidance requirements, including FDA, GMP, and other relevant standards.
• Preparing, reviewing, and maintaining detailed documentation of validation and compliance activities, including CAPAs, change controls, protocols, deviations, and reports.
• Assist with investigations into deviations from standard procedures, evaluates and implements corrective and preventative actions to prevent recurrence.
• Support the QA Compliance team as part of the Production Engineering and Maintenance team during investigations.
• Evaluates and provides training to staff on compliance requirements and cGMPs.
• Manages compliance project resolutions, including scheduling, resource allocation, and milestone tracking.

Qualifications:

• Associates degree required. Bachelors of Science strongly preferred.
• 5+ years of pharmaceutical experience require.
• Trackwise Quality Management System.
• Master Control EDMS.
• SAP.
• Blue Mountain Regulatory Asset Management (BMRAM).
• Microsoft Office (Word, Excel, PowerPoint and Teams) experience required.
• Working knowledge of US and EU GMPs.
• Must have excellent attention to detail, ability to multi-task, and manage time effectively.

Shift: Day

Compensation:

• The salary range for this position is $76,000 - $142,800 depending on experience.
  • 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.

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

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