Engineering Compliance Specialist

Morgan McKinley; Carlow; On-site; EUR 45,000 - 65,000; Full time

Job summary

Morgan McKinley is seeking an Engineering Compliance Specialist (P2) to join our client site in Carlow, Ireland. You will drive deviations, CAPAs, and change controls, while ensuring cGMP compliance and proper documentation across cross-functional teams.

The role emphasizes audit readiness, regulatory understanding, and collaboration with Quality, IPT, and EHS to maintain product supply and compliance in a sterile environment.

Qualifications

• Diploma or higher preferred, in a related discipline.
• Experience in a manufacturing GMP setting.
• Strong communication and interpersonal skills.
• Knowledge of regulatory codes and European standards.

Responsibilities

• Direct and/lead deviations and out-of-tolerance conditions with root cause analysis and CAPA.
• Support engineering documentation review and electronic logs.
• Assist in audit readiness activities and internal audits.
• Collaborate with IPT, Quality, EHS, and Technical Engineering to maintain compliance.
• Ensure adherence to cGMP requirements in daily activities and tasks.
• Contribute to a safe and compliant culture at the Carlow site.

Skills

Regulatory knowledge

Communication skills

Root Cause Analysis

Documentation skills

Time management

Attention to detail

Cross-functional teamwork

Problem solving

Multitasking

Organizational skills

Education

Diploma or higher

Tools

Microsoft Office

Job description

Engineering Compliance Specialist (P2)- Job Description

We are seeking an Engineering Compliance Specialist to join our Engineering Department at our clients site, supporting operations in a GMP and Sterile Environment. 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.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• 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.

What skills you will need:

In order to excel in this role, you will more than likely have:

• 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
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers
• Understand the specific responsibilities of all Carlow departments as they relate to one's own department, understanding the business processes one's department supports
• Effective time management and multi-tasking skills
• Proven organizational skills
• Excellent attention to detail