Jobs and Careers

Senior Serialisation (Automation) Engineer

Irelandfull_timeVerifiedPosted 13 Jun 2024

About the role

Who We Are

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. Senior Serialisation (Automation) Engineer Location- Hybrid to Shanbally, Cork, Ireland The Senior Serialisation Engineer is a member of the Automation Engineering team who are accountable for the Automation & Control engineering support for Drug Substance, Sterile Drug Product and Packaging and Labelling operations. Key aspects of this role are to provide technical engineering support to Packaging and Labelling operations and the project team ensuring successful commissioning and qualification of new Packaging equipment. The Senior Automation Engineer will have accountability for Serialisation / Automation engineering support for day to day operations ensuring the delivery of secondary packaged product from the Shanbally RESPONSIBILITIES:

Provide Serialisation / Automation engineering input to support the secondary packaging of drug products, syringes, vials and pens on packaging lines at BioMarin Shanbally.
Lead / Execute the design, engineering and commissioning of new control systems.
Provide process design support to ensure successful qualification and operation of a new Packaging equipment.
Lead Automation sub teams to deliver department goals and Continuous improvements.
Lead assigned technical area sub team and act a site SME for the assigned technology platform.
Provide technical control engineering support for process fit to plant workshops to ensure successful technology transfers of new products.
System Owner for Site Serialisation System
Responsible for Serialisation / Automation engineering design and optimisation.
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.
Ensure relevant Serialisation / Automation systems 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.
Instill the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
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 Serialisation / Automation systems Bio-process engineering.
Providing coaching and support to the Operations team to build their knowledge of Serialisation / Automation systems.
Maintains professional and technical knowledge by attending workshops, reviewing professional publications; establishing professional networks and participating in professional societies.

EDUCATION

Bachelor Degree Engineering, Information Technology, Instrument Physics, Electrical Engineering or equivalent discipline.
Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework).

EXPERIENCE