Engineering Compliance Specialist

PE Global; Carlow; On-site; EUR 55,000 - 75,000; Full time

Job summary

PE Global is seeking an Engineering Compliance Specialist for a leading Biotech client in Carlow. This 11-month contract role is initially 4 days onsite per week, with potential move to 3 days after six months.

You will drive compliance, review GMP documentation (CAPAs, deviations), lead change controls, author and review controlled documents, and collaborate across IPT, Quality, EHS, and Engineering to ensure regulatory readiness.

Qualifications

• Diploma or higher in a related discipline.
• Experience in a manufacturing GMP setting preferred.
• Strong communication and interpersonal skills.
• Knowledge of Irish, European and International regulatory codes.
• Proficiency in Microsoft Office.
• Lean Six Sigma experience.
• Excellent time management and multi-tasking.
• Ability to interface with cross-functional teams including IPT, Quality, EHS.

Responsibilities

• Lead deviations and CAPAs with root-cause analysis and corrective actions.
• Support engineering documentation review and audit readiness activities.
• Collaborate with cross-functional teams to maintain compliance posture.
• Ensure compliance with cGMP in daily activities and processes.
• Perform other duties as assigned to support regulatory compliance.

Skills

Communication skills

Team collaboration

Root Cause Analysis

Attention to detail

Time management

Problem solving

Lean Six Sigma

Regulatory knowledge

Education

Diploma or higher

Tools

Microsoft Office

Electronic documentation systems

Job description

PE Global is currently recruiting for an Engineering Compliance Specialist for a leading multi-national Biotech client based in Carlow.

This is an initial 11-month contract position, initially 4 days onsite – could move to 3 days after 6 months.

ROLE:

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 at site.
• May be required to perform other duties as assigned.

REQUIREMENTS:

• 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

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***