Pharmaceutical & Biotechnology

Engineering Compliance Specialist

Posted 2 days ago
Contract
Carlow, County Carlow, Ireland
42141935

Desired Skills: GMP,Compliance,CAPAs

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