The Head of Engineering will provide strategic and technical leadership for all engineering, facilities, and capital project activities at our state-of-the-art pharmaceutical manufacturing site in Ireland. This role is pivotal in ensuring that all site infrastructure, utilities, and equipment operate safely, efficiently, and in full compliance with cGMP and regulatory standards. As a key member of the site leadership team, the Head of Engineering will drive the site's long-term engineering and asset strategy, oversee capital investment programs, and lead multidisciplinary teams through the commissioning, qualification, and commercial readiness phases of operations. The successful candidate will be an accomplished engineering leader with deep expertise in pharmaceutical or aseptic manufacturing, a strong background in facility and equipment design, and a proven ability to inspire high-performing teams while fostering a culture of safety, accountability, and continuous improvement.
Major accountabilities:
* Execute project management and partnering strategy for the site, coordinate internal and external workforce including equipment and facility vendors.
* Build project and operational engineering teams for the site.
* Create a culture of accountability within the engineering and facilities teams based on inspired, curious, unbossed principles, leading by example.
* As a member of the site leadership team, drive strategic decisions and develop a Site Master Plan outlining a 5-year plan including forecasted volumes, expenses, and Capex supporting business needs.
* Recruit, train, and develop competent, high performing team members and maintain a robust succession plan.
* Lead a team of engineers and project managers to prepare site for commercial launch, including commissioning and qualification of rooms and equipment.
* As a peer and in collaboration with the Site Quality Head and Head of Production, reach decisions with respect to batch disposition, investigation of out of trend or out of specification results, change, and corrective and preventative actions.
* Utilize incident management, corrective/preventative action, risk analyses, and other programs to drive improvement in all aspects of quality, health and safety, and environmental performance.
* Lead team to implement a Computerized Maintenance Management System that facilitates cost-effective repair, maintenance, and calibration of equipment to prevent unplanned outages.
* Manage capital investment budget & project portfolio for site after operations commence.
Essential requirements:
* BSc degree in engineering or related field or equivalent relevant experience.
* Solid engineering experience in cGMP manufacturing operations with at least 5 years of at a director level
* Previous relevant leadership experience within an engineering and maintenance GMP plant, including design of facilities according to Lean concepts in material, people, and waste flows, preferably in aseptic manufacturing and radiopharmaceutical processing.
* Excellent knowledge of engineering standards in building, facilities and equipment within the pharmaceutical industry along with management of construction projects.