Operations Specialist II

Job Title

Operations Specialist II

Requisition

JR000014427 Operations Specialist II (Open)

Location

Dublin, IRL

Additional Locations

Job Description Summary

The Manufacturing Operations Specialist directly executes dispensing and manufacturing activities. The role must execute all activities in compliance with the required safety and compliance procedures, while ensuring schedule requirements meet the business needs. Included in the role is identifying and implementing actions to improve the existing processes, to optimise the processes, to improve reliability and to eliminate waste.
The role must have a strong work ethic, be self-motivated, require little supervision, and have a desire to continue learning and improving. The role must have a strong sense of responsibility, a high emphasis on Quality, Integrity, Discipline and Teamwork.
As an integral part of the Operations Team, the role supports all Operations’ responsibilities, including taking ownership of specific activities and interactions with support functions.
The role reports directly to the Manufacturing Operations Lead.

Job Description

Roles and Responsibilities

Manufacturing Operations:

• Execute all dispensing, cleaning and manufacturing tasks associated with the preparation for and production of Mallinckrodt products in cGMP environment ensuring full attention to detail and excellent documentation skills.
• Maintain a safe, cGxP compliant work environment at all times.
• Complete all tasks according to SOPs and production batch records (PBR's).
• Proactively identify and communicate compliance, safety and schedule adherence risks.
• Participate in project teams and improvement initiatives.
• Take ownership of specific actions within Operations. E.g. documentation management, area inspection, out of specification investigation, logbook review, etc.
• Support Engineering, Calibration, Maintenance and Qualification activities.
• Proactively engage in EHS inspections and other improvement processes.
• Provide input into the creation and maintenance of area SOPs and batch records.
• Assist with the training of colleagues in SOPs, process execution and equipment operation.
• Provide support to the Quality function 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.
• Resolve issues within area of control to ensure smooth running of manufacturing area.
• Comply rigidly with processes for the protection of intellectual property.
• Act as designee / point of contact for Manufacturing Operations Lead when required.
• Membership of the Emergency Response Team as appropriate.

Additional:

• Participate in Ad hoc projects, goals and objectives as they arise.
• This is not a shift based role, but will require flexibility as part of the support of the manufacturing process.

Experience, Qualifications and Education Requirements

• Minimum certificate level qualification in a related discipline (Chemistry, Engineering, Biotechnology etc.) and / or 2-5 years relevant experience in a cGMP commercial manufacturing environment.
• Working knowledge of production operations with a strong focus on attention to detail and compliance to all regulatory standards.
• Knowledge of GMP utility systems (i.e., WFI, clean steam, pharmaceutical gas systems).
• Experience working in a Grade C / D environment.
• Experience of dispensing operations.
• Experience in non-conformance initiation and investigation.
• Ability to work in a team based environment.
• Excellent organizational and coordination skills.
• Experience with SAP ERP system an advantage.
• Experience in the application of lean principles and structured problem-solving techniques.
• Demonstrated ability to identify improvement initiatives.
• An ability to work independently and as part of a team. The successful candidate will be able to organise their own work on a routine basis and requires minimal supervision.
• Experience in working in cross-functional teams.
• This job description indicates the general nature and level of work expected of the candidate. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. The candidate may be asked to perform other duties as required, particularly in support of critical manufacturing activities.

Competencies / Preferred Skills

• Good interpersonal and communication skills.
• Excellent documentation skills.
• Thorough, diligent, rigorous attention to detail.
• Collaborator with strong levels of engagement with individuals and team.
• High level of delivery and work completion.
• Enthusiastic, flexible, keen to develop.
• Ability to manage ambiguity and change.
• High levels of integrity and trustworthiness.
• Ability to operate effectively with minimum supervision.
• Demonstrated ability to lead change.
• Working knowledge of six sigma and lean tools.
• Ability to build a culture of positive engagement.