Engineering Compliance Specialist

RECRUITERS; Carlow; On-site; EUR 45,000 - 55,000; Full time

Job summary

RECRUITERS in Carlow is seeking an Engineering Compliance Specialist for an 11-month contract on site in a GMP environment. The role focuses on deviation management, CAPAs, change controls, and audit readiness, with collaboration across Engineering, Quality and EHS teams.

The successful candidate will support regulatory compliance, risk assessments and process improvements to maintain cGMP standards. Salary starts at €50,000 per annum, with the appointment based in Carlow.

Qualifications

• Analytical, problem-solving and strong communication skills are required.
• Experience defending regulatory and quality standards in GMP environments.
• Experience preparing and maintaining technical or GMP documentation.

Responsibilities

• Lead investigations into deviations and CAPAs, including RCA and CAPA implementation.
• Support Engineering Change Controls ensuring GMP compliance.
• Prepare, review and maintain GMP documentation and controlled documents.

Skills

Analytical thinking

Problem solving

Communication skills

Stakeholder management

Organisational skills

Education

Diploma or higher in Engineering/Science/Quality

Tools

Microsoft Office

Electronic documentation systems

Job description

Engineering Compliance Specialist – Carlow

We are seeking an Engineering Compliance Specialist to join a leading pharmaceutical manufacturing site in Carlow on an 11-month contract role.

The successful candidate will work within the Engineering Centre of Excellence (CoE), supporting engineering compliance activities in a highly regulated GMP and sterile manufacturing environment.

This role focuses on deviation management, CAPAs, change controls, audit readiness and GMP documentation, ensuring engineering activities meet regulatory and quality standards.

Key Responsibilities

• Lead and support investigations into deviations, out-of-tolerance conditions and unexpected results, including Root Cause Analysis (RCA) and CAPA implementation.
• Manage and support Engineering Change Controls, ensuring compliance with GMP requirements.
• Prepare, review and maintain GMP documentation, including deviation reports, electronic logs, SOPs and controlled documents.
• Support internal audits, regulatory inspections and ongoing inspection readiness.
• Collaborate with Engineering, Quality, EHS and Technical teams to resolve compliance issues
• Ensure compliance with cGMP, regulatory standards and internal quality procedures.
• Support risk assessments, process improvements and compliance-related investigations.

Requirements

Essential:

• Previous experience in Engineering Compliance, Quality Compliance or a related role within a regulated environment.
• Knowledge of GMP/cGMP requirements, deviation investigations, CAPAs and change control processes.
• Experience preparing, reviewing and maintaining technical or GMP documentation.
• Strong analytical, problem‑solving and root cause analysis skills.
• Excellent communication, organisational and stakeholder management skills.
• Proficiency in Microsoft Office and relevant electronic documentation systems.

Desirable:

• Diploma or higher qualification in Engineering, Science, Quality or a related discipline.
• Previous experience within pharmaceutical or medical device manufacturing.
• Experience supporting sterile manufacturing or sterile filling equipment.
• Knowledge of Lean Six Sigma methodologies.
• Familiarity with SOX compliance, internal audits and risk assessments.
• Knowledge of Irish, European and international regulatory standards.

This is an 11-month contract position based in Carlow, with a salary starting from €50,000 per annum.

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