- 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 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 Engineering and Reliability Lead is responsible for implementing an asset care strategy at company in order to maximize equipment up time and increase operations resiliency.
- Provide a life-cycle approach to asset care from design to retirement and re-investment.
- Develop, promote and Instill a culture of asset resiliency, care, and optimization
- Optimize and maintain a clear, efficient and robust process for the planning and scheduling of all maintenance work
- Responsibility for the accurate planning, budgeting and control of the maintenance and budget spend
- Responsible for reducing the cost of maintenance across the plant through establishing methods to track cost of maintenance on a per asset/system basis while focusing on reducing cost Derive performance metrics to indicate the efficiencies and bottlenecks within the maintenance functions
- Responsibility for ensuring that all maintenance activities are performed in line with local, corporate and external regulatory agency standards
- Ownership of site facilities master plan, controlling asset life-cycle investment providing inputs into site capital investment
- Challenging engineering practices to ensure efficient process and system
- Assist all areas of maintenance execution to eliminate repeat issues, compliance risks and inefficiencies
EDUCATION AND EXPERIENCE
A relevant third level qualification in either, in Engineering or Science or equivalent GMP work experience in Bio-pharmaceuticals or equivalent industry.
The successful candidate will have :
- Experience in GXP/Non GXP change management, deviations and CAPA programs.
- A proven track record of developing and maintaining an operating budget and providing key metrics for adherence
- A proven track record of running maintenance scorecards/metrics for internal and external departments
- A demonstrated 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.
- Proven track record in maintenance/reliability work management practices including effective planning and scheduling.
The successful candidate is preferred to have:
- Experience in dealing with regulators i.e. FDA, IMB and HSA and EPA and preparing a site for a PAI.
- Experience in outsourcing maintenance/reliability and utility operations
Engineering and Reliability Lead will interact with other Engineering personnel and personnel from Validation, Quality Control, Quality Assurance, Purchasing, Manufacturing and manufacturing science, EHS and external Vendors when necessary.
- Responsible for a group of engineers, planner schedulers, technicians and graduates who form the Asset Health Program team.
- This currently composes of 13 resources.
- This number will change as site activities demand.