Site Engineering Director

Job Description

A fantastic opportunity has arisen for a Site Engineering Director. This position will lead the team and set the strategy for driving engineering, maintenance, reliability, sustainability, facilities, utilities and projects expertise to deliver for clinical and commercial manufacturing at our Biologics commercialisation facility at Dunboyne. Reporting to the Site Operations Lead, the Site Engineering Director will provide leadership and engineering technical expertise to Biologics drug substance (DS) clinical and/or commercial manufacturing, technology transfers, projects, utilities, site infrastructure, and facilities management.

Bring energy, knowledge, innovation to carry out the following:

• Serve on the Site Leadership Team to develop and deliver toward site priorities.
• Drive a strong compliance mindset within the organisation, including proactive safety and quality culture, adherence to all regulatory expectations (GMP and EHS) and permanent inspection readiness programs.
• Manage, coach, and mentor the site engineering team, including Maintenance, Utilities, Facilities, and Engineering Center of Excellence.
• Provide engineering excellence for the site through design, construction, validation, start up, technology transfer and clinical and commercial manufacturing.
• Lead and/or support various site functional and cross functional communication and escalation structures.
• Plans and directs all aspects of engineering/facilities/utilities activities and ensures that all engineering projects, initiatives and processes are in conformance with established policies, standards and objectives.
• Establish and deliver on KPI’s in a timely manner, including maintenance adherence, facility start up, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, Right First Time, and timely documentation closure.
• Ensure facilities, engineering and any new project milestones are achieved through planning and execution of integrated overall program schedule.
• Provide clear direction and definition of engineering and any new project scope, goals and deliverables, to the site and cross-functional sub-teams on an on-going basis.
• Resolve resource constraints and support resource needs and changes.
• Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders.
• Responsible for prioritisation of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process.
• Drive execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model.
• Manage financial forecasts and workload to achieve departmental headcount and cost improvements.
• Manage and develop team personnel toward strong, empowered leaders. Build, inspire, reward and develop diverse talent with the capabilities necessary to grow and succeed.
• Drive a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organization and manufacturing processes.
• Own accountability for site engineering positions on various site Councils and governance; eg, Quality Council, EHS Council, Operational Readiness, Quality Risk Management, Finance Council, etc.
• Participate and Comply with our Manufacturing Division Quality Management System (QMS) and EHS requirements, including topic ownership, effective implementation and continuous improvement, as applicable.

Preferred Qualification and Experience:

• Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies).
• Demonstrated leadership with at least 10 years leading in a cross-functional environment.
• Demonstrated biotech/vaccines/pharma manufacturing site, project or other relevant experience.

General/Technical Competencies: