Pharma Engineering Director — CapEx, Compliance & Growth

Morgan McKinley; Galway; On-site; EUR 150,000 - 190,000; Full time

Job summary

Morgan McKinley is seeking a Director of Engineering for its Galway pharmaceutical manufacturing site. The role reports to the site leadership team and focuses on manufacturing excellence, regulatory compliance, and strategic capacity planning across multiple sites.

The successful candidate will lead large-scale capital projects, manage CapEx, and drive process development, technology transfer, and automation to improve efficiency while ensuring GMP and ISO standards are met.

Qualifications

• 15+ years in sterile manufacturing in senior leadership roles.
• Strong understanding of Annex I, US and EMA GMP regulations with audits experience.
• Aseptic process expertise including contamination control strategies.
• Proven leadership and cross-functional collaboration skills.

Responsibilities

• Define and implement engineering strategies aligned with business goals.
• Lead large-scale capital projects and CapEx budget management.
• Oversee process development, technology transfer, and automation initiatives.
• Ensure compliance with HPRA, FDA, GMP, cGMP, ISO.
• Oversee IQ/OQ/PQ validation protocols for pharmaceutical manufacturing.
• Collaborate with Quality, EHS and Regulatory teams for safety and compliance.
• Optimize HVAC, cleanrooms, water treatment, and aseptic processing systems.
• Drive sustainability initiatives to reduce waste and energy usage.
• Lead multi-site engineering teams and global operations.
• Develop talent through mentorship, training programs and succession planning.
• Oversee engineering budgets and ROI on capital expenditures.
• Identify and mitigate risks in production, supply chain and facility operations.
• Develop and promote an RCM strategy using FMECA/FMEA and data review.

Skills

Leadership

Regulatory

Quality systems

Cross-functional

Education

Bachelor's or Master’s in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field)

Job description

Morgan McKinley is seeking a Director of Engineering for its Galway pharmaceutical manufacturing site. The role reports to the site leadership team and focuses on manufacturing excellence, regulatory compliance, and strategic capacity planning across multiple sites.

The successful candidate will lead large-scale capital projects, manage CapEx, and drive process development, technology transfer, and automation to improve efficiency while ensuring GMP and ISO standards are met.