Operations Specialist III

Job Title

Requisition

Location

Additional Locations

Job Description Summary

The Shift Operations Specialist will be directly involved in the manufacture of our products to the highest standards of safety, potency, efficacy and quality. The role will work within the guidelines of cGMP to ensure conformance with all regulatory requirements and site SOPs, while assisting in the implementation of process improvements and enhancements.

Job Description

Responsible for execution of all tasks associated with the preparation for and production of Mallinckrodt

products in a cGMP environment ensuring full attention to detail and excellent documentation skills.

• Assist in maintaining a safe, cGxP compliant work environment at all times.
• Responsible for completion of tasks according to SOPs and Production batch records (PBR’s)
• Participate on project teams through all phases of the start-up projects; these phases will include Equipment

installation and start up, commissioning, validation, and qualification of equipment.

• Support introduction of new products into sustaining operations through the execution of Product

Demonstration and Validation activities

• Support Engineering, calibration, and utility equipment maintenance activities - Perform initial troubleshooting

of issues identified during start-up and routine operations.

• Drafting and updating of area SOPs, and batch records.
• Assist with the training of colleagues in SOPs, process execution and equipment operation.
• Provide support to Quality Operations where required.
• Drive a culture of Engagement and Continuous Improvement through identifying and implementing

opportunities for improvement in process efficiency and compliance.

• Provide support for initiation and completion of deviations, CAPAs, and change controls for process systems

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.