Director of Engineering

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

The Role & What You Will Be Doing

The Director of Engineering will be responsible for all activities relating to the day-to-day manufacturing of pharmaceutical products at the client's facilities in Galway, Ireland. In collaboration with the other members of the site leadership team, the Director of Engineering will be part of the senior management team that is responsible for culture, corporate citizenship, strategic planning, and ensuring long term viability of the site. This position has high accountability for decision making and supply chain reliability and will work cross-functionally to ensure the products meet standards for quality, inventory levels are satisfactory, and budget goals are achieved. This position will also be responsible for long term capacity planning.

Every day, we rise to the challenge to make a difference and here’s how the Director of Engineering role will make an impact:

• 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 manage external contractors/consultancy agreements


• 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

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• 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