Engineering Compliance Specialist

Life Science Recruitment; Carlow; Híbrido; EUR 45.000 - 60.000; Jornada completa

Descripción de la vacante

Life Science Recruitment is seeking an Engineering Compliance Specialist for a 11-month contract in Carlow. The role focuses on ensuring compliance, safety, and reliable product supply, including reviewing GMP documentation and leading change controls.

Responsibilities include authoring and reviewing controlled documents, conducting RCA with cross-functional teams, and maintaining regulatory compliance across Irish, European, and international standards.

Formación

• Diploma or higher in related discipline.
• Experience in manufacturing GMP setting is preferred.
• Effective communication and interpersonal skills.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report and policy writing skills.
• Lean Six Sigma methodology experience.

Responsabilidades

• Direct and lead deviations, out of tolerance conditions and unexpected results; conduct root cause analysis and implement corrective actions.
• Support Engineering documentation review (electronic logs).
• Support Audit Readiness activities.
• Support Internal Audit programs.
• Collaborate with Engineering and other departments to maintain compliance posture.
• Ensure compliance with cGMP and global policies; promote a safe, compliant culture in Carlow.

Conocimientos

Root Cause Analysis

Regulatory knowledge

Communication skills

GMP knowledge

Educación

Diploma or higher in related discipline

Descripción del empleo

Engineering Compliance Specialist

Days & hybrid

RK26534

Contract 11 months

Carlow

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role is essential for ensuring compliance, safety, and reliable product supply. Key responsibilities include generating and expediting the review of Manufacturing GMP documentation such as deviation reports (QNs) and corrective and preventative actions (CAPAs), leading Engineering change controls and supporting permanent inspection readiness. The Compliance Specialist will also author, edit, and review controlled documents, collaborate within cross-functional teams to solve problems using Root Cause Analysis (RCA) methodologies, and ensure timely completion of documentation to maintain compliance with regulatory requirements.

Key Responsibilities:

• Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective and preventative actions.
• Supporting Engineering documentation review - e.g. electronic logs
• Supporting Audit Readiness activities.
• Supporting Internal Audit programs
• Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks and maintaining compliance posture.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned.

Education and Experience:

• Diploma or higher preferred, ideally in a related discipline.
• Would typically have prior-related work experience; ideally in a manufacturing GMP setting.
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Report, standards, policy writing skills
• Sterile filling processes and equipment experience preferred.
• Proficiency in Microsoft Office and job-related computer applications
• Lean Six Sigma Methodology experience