Process Engineer

Location:  Cork, Ireland Category: Manufacturing

Description

Process Engineer

BioMarin 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. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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. 

Process Engineer - reports to the Process Engineering Manager and is responsible for ensuring process engineering activities are implemented in a compliant manner. Provide process engineering services to Manufacturing in a Biologics Drug Product Filling, Packaging and Labelling facility.

The main areas of responsibility are as follows: Provision of technical engineering support to Drug Product Filling, Packaging and Labelling processes including process performance monitoring, troubleshooting and process optimisation.

  • Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products
  • Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
  • Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement and process optimisation using tools such as DMAIC, SMED and FMEA.
  • Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities.
  • Ensures relevant metrics are in place to effectively monitor and report out on operational performance and identify/implement improvement opportunities quickly.
  • Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements.
  • Work collaboratively to drive safe, high quality, and cost-effective manufacturing facilities.
  • Instil the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
  • Responsible for engineering design and optimisation of single use consumables.
  • Ensure adherence to high standards of quality and support of a science and risk based quality culture.
  • Providing coaching and support to the Operations team to build their knowledge of Bio-process engineering.
  • Ensures that all manufacturing methods and practices are consistent with industry and BioMarin standards.
  • Maintains professional and technical knowledge by attending workshops, reviewing professional publications; establishing professional networks and participating in professional societies. 
Education and Experience
  • BA Degree in Engineering - Process, Chemical, Mechanical or equivolent discipline
  • Other continuing education initiatives highly desirable - Six Sigma, Lean Manufacturing, industry specific coursework
  • 5+ years expereince 

 

+5 years experience


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.