A Director of Engineering is required by CareerWise Recruitment for our Galway based client. As Director of Engineering, you will be responsible for providing technical expertise, strategic planning and regulatory compliance to develop and manage capital improvement plans, including the design, installation, and upgrading of equipment, systems, and facilities to ensure that site infrastructure and facilities meet the highest standards of safety, quality, and efficiency. You will have a proven track record of strong people leadership and development. The successful individual will be responsible for building and nurturing high-performing teams, fostering a culture of collaboration, accountability, and continuous improvement. Fully on site role based in Galway, Ireland.
THE ROLE:
- Define and implement engineering strategies aligned with business goals
- Lead large-scale capital projects, including new facility construction, expansions, and equipment upgrades, including the management of the CapEx budget and anage external contractors/consultancy agreements with
- Oversee process development, technology transfer, and automation initiatives to enhance manufacturing efficiency
- Ensure compliance with HPRA, FDA, GMP, cGMP, ISO, and other global regulatory standards.
- Oversee the development and maintenance validation and qualification protocols (IQ, OQ, PQ) for pharmaceutical manufacturing
- Partner with Quality, EHS and Regulatory teams to ensure product safety and compliance
- Collaborate with Operational Excellence teams to optimize HVAC, cleanrooms, water treatment, and aseptic processing systems to maintain sterile environments
- Drive sustainability initiatives, reducing waste and improving energy efficiency in operations
- Lead multi-disciplinary engineering teams across multiple sites and global operations
- Develop talent through mentorship, training programs, and succession planning
- Oversee engineering budgets, ensuring cost control and ROI on capital expenditures
- Identify and mitigate risks in production, supply chain, and facility operations
- Develop, Implement, and promote a Reliability Centered Maintenance (RCM) strategy using Failure Mode Effects and Criticality Analysis (FMECA/FMEA) assessments in conjunction with department management, the Engineering dept reliability engineer and the Production department utilizing tools such as Trend’s analysis & Control charts & Data review
REQUIREMENTS:
- Bachelor's or Master’s in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field).
- PMP, Six Sigma Black Belt, Lean Manufacturing certified preferred
- 15+ years in sterile manufacturing in senior leadership roles
- Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
- Aseptic Process Expertise, proven experience in contamination control strategies, including cleaning and disinfection validation.
- Leadership Skills: Strong ability to mentor and develop teams
- Risk assessment & problem solving capabilities
- Communication & Collaboration: Excellent ability to articulate requirements and collaborate cross-functionally to drive compliance and process improvements
