Galway Director of Engineering - Pharma Facilities Leader

CareerWise Recruitment; Galway; On-site; EUR 140,000 - 190,000; Full time

Job summary

CareerWise Recruitment is seeking a Director of Engineering for a Galway-based, on-site role. You will lead engineering strategy, manage multi-site capital projects, and ensure regulatory compliance across HPRA, FDA, GMP and ISO standards.

You will drive process development, automation initiatives, and validation programs while mentoring high-performing teams and optimizing facilities to meet safety, quality, and efficiency targets.

Qualifications

• Bachelor's or Master's in Mechanical, Chemical, Biomedical, Industrial, or related engineering field.
• 15+ years in sterile manufacturing in senior leadership roles.
• Strong understanding of Annex I, US, and EMA GMP regulations; practical regulatory audits experience.
• Aseptic process expertise with contamination control strategies, including cleaning and disinfection validation.
• Proven ability to mentor and develop teams; excellent communication and cross-functional collaboration.

Responsibilities

• Define and implement engineering strategies aligned with business goals.
• Lead large-scale capital projects including facility construction, expansions, and equipment upgrades; manage CapEx budget and external contractors.
• 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 of validation 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.
• Drive sustainability initiatives, 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 with cross-functional teams.

Skills

Leadership

Regulatory knowledge

Aseptic processing

Project management

Budget management

Vendor management

Cross-functional collaboration

Quality & compliance

Education

Bachelor's or Master's in Engineering

Job description

CareerWise Recruitment is seeking a Director of Engineering for a Galway-based, on-site role. You will lead engineering strategy, manage multi-site capital projects, and ensure regulatory compliance across HPRA, FDA, GMP and ISO standards.

You will drive process development, automation initiatives, and validation programs while mentoring high-performing teams and optimizing facilities to meet safety, quality, and efficiency targets.