MSD Compliance Engineer 

Ireland 

975429511

Job Description

We are seeking a Compliance Engineer to join our Engineering Department at our Carlow 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), supporting global audit readiness, and participating in audits. The Compliance Engineer 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 actions.
• Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies.
• Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, JSA’s, PM's and change controls.
• Accountable for leading investigation analysis, identifying true root cause, identifying gaps and actions to close gaps. Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks.
• Required to comply with GlobalPolicies, ProceduresandGuidelines,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.
• Support Audit Readiness activities.

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, preferably 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 ones department supports
• Effective time management and multi-tasking skills
• Proven organizational skills
• Excellent attention to detail

please apply today.

Current Contingent Workers apply

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