Operations Specialist

1 week ago

Dublin, Dublin City, Ireland MNK - Mallinckrodt plc Full time
Overview

Operations Specialist at Mallinckrodt Pharmaceuticals — Dublin, IRL

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 works within the guidelines of cGMP to ensure conformance with regulatory requirements and site SOPs, while assisting in the implementation of process improvements and enhancements.

Responsibilities
  • Responsible for execution of all tasks associated with the preparation for and production of Mallinckrodt products in a cGMP environment with attention to detail and excellent documentation skills.
  • Assist in maintaining a safe, cGxP compliant work environment at all times.
  • Complete tasks according to SOPs and Production Batch Records (PBRs).
  • Participate on project teams through all phases of start-up projects, including equipment installation/start-up, commissioning, validation, and qualification of equipment.
  • Support the introduction of new products into sustaining operations through Product Demonstration and Validation activities.
  • Support Engineering, calibration, and utility equipment maintenance; perform initial troubleshooting during start-up and routine operations.
  • Draft and update area SOPs and batch records.
  • Assist with 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 by identifying and implementing opportunities for process efficiency and compliance.
  • Provide support for initiation and completion of deviations, CAPAs, and change controls for process systems.
Minimum Requirements
  • Working knowledge of production operations with strong attention to detail and compliance with regulatory standards.
  • Ability to work independently and as part of a team; capable of organizing own work with minimal supervision.
  • Minimum certificate level qualification in a related discipline (Chemistry, Engineering, Biotechnology, etc.) plus 2–3 years of relevant experience in a cGMP commercial manufacturing environment.
  • Knowledge of GMP utility systems (e.g., WFI, clean steam, pharmaceutical gas systems) is desirable.
  • Experience in working in cross-functional teams.
  • Good interpersonal and communication skills (verbal and written); collaborative with strong engagement with individuals and teams.
  • High level of delivery and ability to complete work; proven track record of delivering on commitments.
  • Knowledge of Continuous Improvement principles and tools.
Organizational Relationship / Scope

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

Working Conditions

This is a day-based role with a flexibility allowance as part of the remuneration package to cover ad-hoc out-of-office batch scheduling requirements. On-site work is a requirement due to the frontline nature of the position.

Disclaimer

The statements describe the general nature and level of work performed by employees in this classification and are not an exhaustive list of all responsibilities, duties or skills required.


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