Engineering Compliance Specialist

Engineering Compliance Specialist

A fantastic opportunity has arisen for an Engineering Compliance Specialist in our newest state‑of‑the‑art, fully integrated vaccine facility in Dundalk. Your role will be critical in ensuring that all engineering activities comply with internal standards, industry regulations, and global pharmaceutical quality requirements.

Responsibilities

• Investigations & CAPA: lead deviation and out‑of‑tolerance investigations from start to finish, including failure analysis, root cause identification, and implementation of corrective and preventive actions; author clear, defensible investigation reports.
• Audit readiness & inspection support: own the Engineering Department’s audit readiness programme and serve as engineering liaison during internal, external, and regulatory inspections (HPRA, FDA, EMA). Ensure timely, accurate and compliant responses.
• Metrics & trending: prepare and analyse quality metrics and trend reports; use data to drive continuous improvement in compliance and operational performance.
• Procedures, change control & documentation: maintain and periodically review engineering SOPs, protocols and compliance documentation; support change controls to ensure alignment with regulatory requirements and internal standards.
• Risk assessment: participate in Quality Risk Assessments and risk assessments for engineering changes, maintenance activities and capital projects.
• Validation & qualification support: support validation/qualification of engineering systems and equipment, ensuring regulatory adherence and documentation quality.
• Training & coaching: coach engineering personnel on GMP, compliance requirements and best practices.
• Cross‑functional delivery: work closely with Facilities, Projects, Quality, EHS and Technical Engineering teams; engage and, where necessary, challenge stakeholders, including escalating compliance risks to senior leadership.

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical or related discipline).
• Proven experience in engineering compliance, quality assurance or validation within pharmaceutical manufacturing or a regulated industry.
• Strong knowledge of GMP, FDA, EMA regulations and pharmaceutical engineering standards.
• Experience with engineering validation, qualification and documentation practices.
• Excellent attention to detail and strong analytical skills.
• Effective communication and interpersonal skills for cross‑functional collaboration.
• Ability to manage multiple tasks and prioritise in a fast‑paced environment.
• Proficiency with compliance management systems and Microsoft Office applications.

Preferred Skills

• Knowledge of risk management and CAPA processes.
• Experience with computerized maintenance management systems (CMMS).
• Vendor management experience.

Equal Opportunity Statement

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing inclusive, talented and committed people together.