Associate Director of Engineering

CareerWise Recruitment; Connacht; On-site; EUR 120,000 - 180,000; Full time

Job summary

CareerWise Recruitment seeks an Associate Director of Engineering for our Galway client. This senior role leads maintenance, facilities and utilities teams, developing strategies to ensure safe, compliant and efficient operations across site infrastructure including HVAC, water systems, power distribution and cleanrooms.

You will drive multi-year capital plans, oversee validation and qualification activities (IQ/OQ/PQ), ensure compliance with HPRA, FDA, GMP, ISO standards and partner with

Qualifications

• Extensive plant engineering leadership experience in the pharmaceutical industry with sterile drug manufacture and cGMP familiarity.
• Experience with regulatory audits (HPRA, FDA) and GMP regulations.
• Proven ability to lead multidisciplinary maintenance, engineering and facilities teams.

Responsibilities

• Lead maintenance, engineering and facilities teams to high performance.
• Develop and execute multi-year engineering and capital investment strategies.
• Drive reliability, asset lifecycle management, preventive maintenance and problem solving across site infrastructure including HVAC, water systems, power distribution and cleanrooms.
• Develop and promote a Reliability Centred Maintenance strategy using analyses and control charts.
• Oversee validation protocols (IQ, OQ, PQ) for pharmaceutical equipment and facilities.
• Ensure compliance with HPRA, FDA, GMP, cGMP, ISO and audits readiness.
• Manage capital budgets and oversee projects and upgrades.
• Collaborate with Manufacturing, Quality, Supply Chain and MS&T to align on needs and sustainability goals.

Skills

Maintenance leadership

Regulatory compliance

Cross-functional leadership

Education

Bachelor’s or Master’s degree in Engineering

Job description

An Associate Director of Engineering is required by CareerWise Recruitment for our Galway based client. The Associate Director of Engineering (Equipment, Facilities & Utilities Maintenance) is a senior leadership role responsible for developing and executing maintenance strategies for equipment, facilities, and utility systems, ensuring alignment with organisational goals, regulatory requirements, and industry standards while maintaining high levels of safety, quality, compliance, and efficiency. Strong Maintenance / Engineering skillset required in the Pharma industry. Exceptional opportunity to progress.

THE ROLE:

• Lead, mentor and develop multidisciplinary maintenance, engineering and facilities teams, fostering accountability, engagement and high performance.
• Develop and execute multi-year engineering and capital investment strategies to support capacity, compliance and business growth.
• Drive engineering reliability, asset lifecycle management, preventive maintenance and technical problem-solving across site infrastructure including HVAC, water systems, power distribution and cleanrooms.
• Develop, implement and promote a Reliability Centred Maintenance (RCM) strategy using FMECA/FMEA assessments, trend analysis and control charts to optimise equipment performance.
• Oversee validation and qualification protocols (IQ, OQ, PQ) for pharmaceutical manufacturing equipment and facilities.
• Ensure full compliance with HPRA, FDA, GMP, cGMP, ISO and other global regulatory standards, supporting inspections and maintaining audit-ready operations.
• Manage annual and multi-year capital budgets, overseeing capital projects and facility upgrades to deliver cost-effective, sustainable solutions.
• Partner closely with Manufacturing, Quality, Supply Chain and MS&T teams to align on operational needs and drive sustainability initiatives.
• This role offers significant growth potential, positioning the successful candidate for progression to Site Engineering Director in the near term, subject to performance.

REQUIREMENTS:

• Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field).
• Extensive plant engineering leadership experience in the pharmaceutical industry, with a strong understanding of sterile drug manufacture and cGMP requirements.
• Strong understanding of Annex I, US and EMA GMP regulations, with practical experience in regulatory audits (HPRA, FDA).
• Proven experience in aseptic process and contamination control strategies, including cleaning and disinfection validation.
• Demonstrated ability to plan, design and manage significant capital expansion projects, with experience in equipment qualification, validation and facilities upgrades.
• Strong people leadership skills with a proven track record of building and developing high-performing, multidisciplinary teams.
• PMP, Six Sigma Black Belt or Lean Manufacturing certification preferred.
• Excellent communication, writing and presentation skills with strong problem-solving and critical thinking ability.