Engineering Manager

Engineering Manager required for a new multinational biopharmaceutical company based in Waterford City. The company is focussed on improving patients’ lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. The company has a portfolio of medicines through its orphan and inflammation groups. The Engineering Manager will report to the Head of Operations and will be responsible for the following areas:
  • Site Maintenance Systems & Strategy
  • Engineering & Maintenance Team Performance
  • Site Utilities operation & maintenance (Black & Clean)
  • Site facilities & building services
  • Site Calibration
  • Site Automation & IT
  • Site Manufacturing Systems
  • Site Health, Safety & Environmental Systems
  • Management of FM support service & performance
  • Equipment performance metrics (OEE, d/time, etc.)
  • Energy management
  • Engineering budgets
Responsibilities
  • Manages the Engineering, Maintenance, Automation/IT and Facilities resources including technicians, engineers and contract resources/partners required to support site objectives.
  • Engineering team recruitment, performance management, training and development plans.
  • Leads the design, introduction and management of site maintenance systems such as CMMS, spares, safety permitting for Engineering and Maintenance personnel.
  • Ensure FUE management system is in place so that we maintain Facilities and Utilities to best in class level, with timely upkeep and reinvestment and delivering energy reduction and sustainability programs & projects.
  • Develop a culture of continuous improvement.
  • Owns site energy, waste performance, energy and waste budgets. Monitors site performance from a budget and environmental perspective. Leads continuous improvement in this area and leads site representation at EHS and Environmental audits.
  • Owns maintenance Service Level Agreements (SLA) and spares budgets to ensure the site is maximising benefit from site maintenance spend.
  • Coordinates site shutdowns from planning, execution, return to service, safety and GMP perspective.
  • Ensures all personnel in their team are diligent in the completion of all documentation to the highest GMP standards.
  • Manages the Horizon Automation team who are responsible for the support of automated systems on site.
  • Ensuring site asset management is compliant with HSA equipment and leads establishment and maintenance of the site’s relationship with our insurers.
  • Represent the site for maintenance/utility in front of HPRA/ FDA / HSA inspectors during audits.
  • Ensure certified EHS Management Systems are in place and maintained
  • Ensure an interdependent safety culture model is put in place
  • Ensure Environmental compliance with our Regulatory Licences
Qualifications, Skills & Experience Required
  • Degree in Building Services/Mechanical/Electrical Engineering or equivalent technical certification/trade in a business service, mechanical, electrical or related field.
  • Postgraduate degree desirable.
  • 15+ years of directly related engineering/maintenance experience in a regulated manufacturing environment
  • 5+ years management experience – building and leading an Engineering team in a pharmaceutical manufacturing environment
  • Understands maintenance system design to ensure excellent asset performance.
  • Familiar with pharmaceutical utility equipment such as WFI generation & distribution, clean steam generation & distribution, cleanroom HVAC, steam boilers, air compressors, etc.
  • Strong technical, troubleshooting and problem-solving skills.
  • Proficient in use of Microsoft Office and other computer applications i.e. CMMS.
  • Knowledgeable of the regulatory and GMP requirements for maintenance activities. Direct experience of HPRA and FDA inspections.
  • Familiar with EHS and Environmental standards.
  • The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time.