- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Maintenance Operations Lead is responsible for the execution of the site maintenance program in a safe and compliant manner. While engaging his/her team to provide high levels of customer service to all departments.
Main areas of responsibility:
- Lead a team of maintenance technicians to execute all aspects of maintenance across the site in a safe and compliant manner
- Responsible for executing the preventive and correct maintenance schedule provided by the maintenance planner/schedulers in line with equipment availability
- Ensure maintenance resources are in place available, trained and qualified to complete all aspects of maintenance on site
- Engage with Asset Health program team members to highlight areas for improvement within the maintenance program
- Ensure process and utilities equipment is maintained in a safe and compliant manner so as to maximize equipment uptime and increase equipment resiliency
- Responsible for implementing and coordinating site apprenticeship program
- Ensure all work is planned adequately so that all required elements are in place to successfully complete a task within scheduled timeframe
- Promote continuous improvement of the site maintenance program throughout the maintenance team
- Engage and develop the team of onsite maintenance technicians. Responsible for coaching and mentoring maintenance technicians
- Control of maintenance shift pattern and required on call process so as to ensure adequate maintenance cover exists and is utilized in an efficient manner
A threlevantird level qualification in either, in Engineering or Science or equivalent GMP work experience in Bio-pharmaceuticals or equivalent industry.
The successful candidate will have :
- Previously demonstrated leadership in a maintenance team or function
- Experience in GXP/Non GXP change management, deviations and CAPA programs.
- Demonstrate a proven track record to lead and influence others, have strong strategic and tactical thinking abilities
- Be committed to working in a team based environment, with a keen focus on colleague involvement, learning/development and performance.
- Provided leadership in the areas of safety, quality and right first time.
- A good working knowledge of a CMMS and spare parts management system.
Experience in dealing with regulators i.e. FDA, IMB and HSA and EPA and preparing a site for a PAI.