SerialisationEngineer

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. 

Serialisation (Automation) Engineer - Closing Date Friday 26th April 2024 

Location- Hybrid to Shanbally, Cork, Ireland

The 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 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. Provide process design support to ensure successful qualification and operation of a new Packaging equipment. 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 At least 7+ years Serialisation / Automation experience in a GMP/GCP compliant operations is required. Expert knowledge of Serialisation, Lateus Secure Track and Trace System, Siemens PLC, Control Networks and SCADA process control platforms. Experience of interfacing with and the use of OSI PI Data Historian In depth knowledge of Serialisation Platforms, SQL Databases, fault finding and ability to propose and implement improvements. In depth knowledge of OPC interfaces including Kepware Knowledge of Siemens PLC software code, fault finding and ability to propose and implement improvements. Detailed knowledge of all GAMP requirements, including traceability & Data Integrity requirements Experience in aseptic/sterile processing design, construction and start-up environment would be an advantage Experience of project lifecycle activities to include the qualification of equipment in conjunction with Project Engineering teams. Experience in drug product packaging and labelling. Proficient in the operation of all equipment used in the respective functional area of responsibility. Demonstrated ability to partner with other functional groups to achieve business objectives required. Strong knowledge of cGMPs and regulatory agency standards and requirements applicable to a pharmaceutical production facility. Superior communication skills – Oral, written and formal presentation skills with senior management, middle management and line staff. Creative problem-solving skills. Comfortable and effective working indirectly through others.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

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