Utilities Engineer / Senior Utilities EngineerLocation Cork, Ireland Apply
BioMarin’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 BioMarin’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.
This role reports to the Principal Engineer. Responsible for running and maintaining utilities in line with cGMP and regulatory requirements, this role provides overall guidance and support as to the running and compliance of plant utilities.
- Site SME for clean utilities system with overall responsibility for the compliant operation of critical clean utilities.
- Support the start-up of all facility utilities (clean and black) from an idle state with the project team.
- Ensure all HVAC systems are running in line with critical area classification standards and parameters
- Utilize Six Sigma tools such as root cause analysis methods to establish root causes to any issues that may arise and implement robust corrective measures.
- Responsible for ensuring that all utilities remain operational, available for use and GxP compliant at all times.
- Setup and review of contracts with BioMarin Legal and QA Representatives.
- Input into site utility master planning efforts to ensure utility design and capacity can meet site and business needs.
- Ensure that maintenance & calibration is carried out in accordance to cGMP regulations, safety considerations and site quality standards.
- Generate, report and analyse key utility metrics.
- Use of permit to work system or other safety systems to control engineering activities.
- Participation in HAZOP and design reviews.
- Ensure that all engineering drawings and documentation are maintained in compliance with relevant cGMPs and GEPs.
- Raising, investigating and closing site quality records such as change requests, deviations, events and actions.
- Identify all critical spare parts required for equipment.
- Development, control and forecasting of site energy budget.
- Planning and execution of site utility shutdowns.
- Other duties as assigned.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.