Basic Summary:
The Head of Engineering is responsible for leading all site engineering, maintenance, utilities, facilities, and capital project activities to ensure a safe, compliant, and reliable pharmaceutical manufacturing environment. This role ensures the site meets GMP, HPRA/FDA/EU regulatory expectations, maintains high equipment reliability, delivers strategic capital investment, and implements long-term engineering excellence to support business growth.
Location:
Onsite at our facility in Loughrea.
As our Head of Engineering your key responsibilities will be as follows:
Leadership & Strategy:
* Develop and execute the site engineering & technical services strategy.
* Lead engineering teams including maintenance, utilities, calibration, projects, facilities, and automation.
* Champion safety, reliability, and continuous improvement.
* Work with value streams to improve OEE & efficiency levels on key production processes.
Engineering Governance & Compliance:
* Maintain GMP-compliant systems and equipment.
* Upgrade and own engineering policies and standards.
* Oversee regulatory inspections and statutory compliance.
Maintenance & Reliability:
* Direct preventive, predictive, and condition-based maintenance.
* Implement reliability engineering practices.
* Reduce downtime and equipment-related deviations.
Capital Projects & Site Expansion:
* Lead the CAPEX portfolio and major site expansions.
* Manage design, construction, C&Q, and handover.
* Control budgets and vendor performance.
* Support new commercial contract enquiries with CAPEX & operational standards (i.e. machine speeds etc.)
Facilities, Utilities & Energy:
* Oversee HVAC, water systems, boilers, chillers, compressed air, and cleanroom utilities.
* Manage facilities, buildings, grounds, and contractor control.
* Drive sustainability and energy-saving initiatives.
Automation, Controls & Digitalisation:
* Own the automation strategy.
* Support MES, data integrity and Industry 4.0 initiatives.
* Ensure cybersecurity for control systems.
Budget, People & Performance:
* Manage operational and capital budgets.
* Develop engineering talent and succession plans.
* Monitor KPIs including OEE and equipment uptime.
Education and Qualifications:
Essential:
* Degree in Engineering.
* 10+ years pharmaceutical or GMP-regulated leadership.
* Strong knowledge of EU GMP, HPRA/FDA requirements.
* Proven CAPEX and maintenance strategy experience.
Desirable:
* Master's degree or Chartered Engineer.
* Lean, TPM, Six Sigma experience.
* Automation and digital transformation exposure.
Skills and Competencies:
* Leadership and communication skills.
* Strategic thinker with strong problem-solving.
* Excellent stakeholder management.
* Data-driven decision-making.
* Ability to manage change in a regulated environment.