This is an 11 Month contract with a view to extending.
Working as part of the Engineering Centre of Excellence, this position will support the Engineering Team and the wider business in the start-up of our State of the Art facility in Meath.
• Act as system owner/subject matter expert for Engineering and relevant EHS management systems and standards, including: – contractor management, permit to work, permit office, engineering business continuity plan, environmental management, statutory inspections, mechanical testing program, emergency response, and engineering technical standards.
• Coordinate and execute gap assessments of current processes against corporate Engineering and EHS standards and industry best practices; identify remediation and ongoing improvement actions and drive to completion.
• Act as site system owner/subject matter expert for the application of corporate engineering and facility design standards to the site.
• Coordinate and execute gap assessments for compliance with the design standards; identify remediation and ongoing improvement actions and drive to completion.
• Continually monitor industry and corporate policies, procedures, standards, and programs; recommend improvements where necessary.
• Liaise with corporate and Ireland-site colleagues on the application of the EHS and engineering standards; take part in cross-site teams to support standardized application across sites.
• Develop and implement safe systems of work for manufacturing and maintenance operations.
• Implement and support the site’s environmental management program.
• Support ongoing assessment and improvement of engineering and facility systems against cGMP requirements, including Quality Management System standards and guidelines.
• Develop and maintain the facility and engineering aspects of the site Business Continuity Plan. Identify and implement process and equipment/facility improvements to control business risks.
• Support equipment and process introduction and modifications through advising on compliance with engineering/facility design standards as part of the Change Management Process.
• Act as engineering representative on relevant cross-functional site projects.
• Lead key sections of the site Emergency Response program, ensuring the program is permanently ready for deployment.
• Provide relevant training and support to colleagues.
• Lead and support relevant site investigations, identifying root cause and measures to prevent a recurrence.
• 3rd level qualification in an Engineering, technical discipline, or equivalent.
• At least 5 years of relevant experience in biotechnology, pharmaceutical industry, or equivalent.
• In-depth knowledge of safety and engineering standards and best practices.
• In-depth knowledge of cGMP regulatory requirements for management of engineering systems and processes.
• Experience in executing risk assessments.
• Knowledge of environmental management programs.
• Experience in the management of safe systems of work.
• A good understanding of manufacturing processes, equipment, utilities, and maintenance practices.
• Understanding of the principles of Business Continuity and the application to a pharmaceutical manufacturing site.
• Experience in investigation and problem solving using structured problem-solving techniques.
• Proven experience in implementing change and project management.
• The ability to think logically and work proactively under pressure.
• The ability to work as part of a team and on own initiative constructively.
• Excellent verbal and written communication skills.