Overview
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 Manufacturing Operations Lead in the Manufacturing Dept.
Location: Dublin, IRL
Requisition: JR000015219 Operations Specialist (Open)
Company: Mallinckrodt Pharmaceuticals
Responsibilities
* 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.
* Ability to work independently and as part of a team; able to organize own work on a routine basis with 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.
* Good interpersonal and communication skills, verbal and written; collaborative with strong engagement with individuals and teams.
* High level of delivery and work completion; proven track record of delivering on commitments.
* Knowledge of Continuous improvement principles and tools.
Organizational Relationship/Scope
The Operations Specialist is a key frontline role reporting directly to the Operations Lead at College Park Mallinckrodt Pharmaceuticals Manufacturing facility.
Working Conditions
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.
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.
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Management and Manufacturing
* Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr