Serialisation (Automation) Engineer

• 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.

• 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).

• 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.

BioMarin