Job Title

Operations Specialist II

Requisition

JR000015603 Operations Specialist II (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Job Description Summary

Job Description
The 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

Job Description

The 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.

The Operations Specialist will assist in facility and equipment modifications, product demonstration and Validation activities as the need arises. The successful candidate will be required to provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.

The Operations Specialist will support safety and quality events, CAPAs and change controls.

The successful candidate will be a person with a strong work ethic, a self-motivated team player with an excellent can-do attitude. The role will have a strong sense of responsibility, a high emphasis on Quality, Integrity, Discipline and Teamwork.

The role reports to the assigned Manufacturing Operations Shift Lead within the Manufacturing Dept.

Essential Functions

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

Minimum Requirements

Education / Experience / Skills:

Working knowledge of production operations with a strong focus on attention to detail and compliance to all regulatory standards.
An ability to work independently and as part of a team. The individual in this position will be able to organize their own work on a routine basis and requires minimal supervision.
Minimum certificate level qualification in a related discipline (Chemistry, Engineering, Biotechnology etc.) plus 2-3 years relevant experience in a cGMP commercial manufacturing environment.
Knowledge of GMP utility systems (i.e., WFI, clean steam, pharmaceutical gas systems) is desirable
Experience in working in cross functional teams.
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.
Good interpersonal and communication skills, verbal and written.
Collaborator with strong levels of engagement with individuals and teams.
High level of delivery and work completion. A proven track record of delivering on commitments.
A knowledge of Continuous improvement principles and tools.

Organizational Relationship/Scope:

The Operations Specialist is a key frontline role reporting directly to the Operations Shift Lead at College Park Manufacturing facility.

Working Conditions:

This will be a shift-based role within a flexible shift pattern based on active process steps. Shift allowance will be provided as part of the renumeration package.

Due to the nature of this frontline position, on site work is a requirement.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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.