Operations Specialist

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

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 Manufacturing Operations Lead in the Manufacturing Dept.

• 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

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.

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

This will be a day-based role with a flexibility allowance as part of the renumeration package to cover ad-hoc out of office batch scheduling requirements. Due to the nature of this frontline position, on site work is a requirement.

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.

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