Senior Specialist, Operations
The Senior Specialist, Operations, will ensure operational excellence and continuous improvement within the shift manufacturing teams. Reporting directly to the Sr. Manager, Primary Manufacturing, you will provide technical and operational support; maintain a strong working knowledge of the manufacturing equipment set, control systems, and site operating systems.
Provide subject matter expertise on Primary Manufacturing including the filling and preparation functions to ensure success for all current and new products and processes.
Serve as a key integrator for cross-functional teams supporting seamless operation of cGMP production, ensuring readiness of manufacturing areas for start-up, process qualification, and validation activities.
Support the manufacturing operations team as a key contributor for projects that implement new technologies and operational process improvements in the GMP manufacturing environment, maintaining processing suites in a compliant and validated state.
Lead or participate in continuous improvement projects, including capacity optimization and cost reduction programs.
Support the development of the Operational Excellence programs and lead Manufacturing Projects with cross-functional stakeholders.
Work with cross functional teams to review, author and revise standard operating procedures and batch records, review technical reports, assist with conducting deviation investigations, and write deviation reports.
Document and communicate all aspects of work and learnings, providing training and mentorship for new personnel.
Assist with metrics tracking and reporting to leadership teams.
Support and participate in internal and external regulatory inspections as necessary.
Qualifications :
Bachelor Degree in Engineering or Business required
5 years related experience in lieu of Bachelor's degree required as long as applicant has HS diploma.
Pharmaceutical experience preferred
Microsoft office experience desired
Production planning desired
Experience in aseptic fill / finish desired
Strong analytical skills and proficiency in data analysis tools and techniques required
Experience in project management and coordination required
Tasks require entering manufacturing areas that require wearing appropriate PPE required
Respirator Clearance Required
Compensation & Benefits :
This is an on-site, full-time position located in Spokane, WA.
Hiring Wage : $81,825.00 $120,000 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 outstand
Operation Specialist • Spokane, WA, US