Director of Engineering, Capital Projects & Compliance

Careerwise Recruitment; Galway; On-site; EUR 120,000 - 180,000; Full time

Job summary

CareerWise Recruitment is recruiting a Director of Engineering for our Galway-based client. You will provide technical leadership, strategic planning, and regulatory compliance to develop capital improvement plans, ensuring safety, quality and efficiency across sites.

You will lead high-performing teams and foster collaboration and continuous improvement. The role emphasizes process development, technology transfer, automation, and ROI on CapEx, with extensive interaction with Quality, EHS and

Qualifications

• Bachelors 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

Responsibilities

• Define and implement engineering strategies aligned with business goals
• Lead large-scale capital projects, including facility construction, expansions, and equipment upgrades with budget management
• Oversee process development, technology transfer, and automation initiatives
• Ensure compliance with HPRA, FDA, GMP, cGMP, ISO and other global regulatory standards
• Develop and maintain validation protocols (IQ, OQ, PQ) for pharmaceutical manufacturing
• Partner with Quality, EHS and Regulatory teams to ensure safety and compliance
• Collaborate to optimize HVAC, cleanrooms, water treatment, and aseptic processing systems
• Drive sustainability, reducing waste and improving energy efficiency
• 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 FMECA/FMEA assessments

Skills

Leadership

Risk assessment

Communication

Regulatory knowledge

Aseptic processing

Project leadership

Mentoring

Education

Bachelor's or Master's in Engineering

Job description

CareerWise Recruitment is recruiting a Director of Engineering for our Galway-based client. You will provide technical leadership, strategic planning, and regulatory compliance to develop capital improvement plans, ensuring safety, quality and efficiency across sites.

You will lead high-performing teams and foster collaboration and continuous improvement. The role emphasizes process development, technology transfer, automation, and ROI on CapEx, with extensive interaction with Quality, EHS and