GMP Compliance Engineer — Sterile Ops & CAPA Lead

Tandem Project Management Ltd.; Carlow; Remote; EUR 52,000 - 84,000; Full time

Job summary

Tandem Project Management Ltd. seeks an Engineering Compliance Specialist to join the Engineering Department of a biopharmaceutical company in Carlow. You will support GMP and sterile operations, drive deviations and CAPA analytics, and assist with change controls and inspection readiness.

You will author and review controlled documents, collaborate with cross-functional teams, and apply Root Cause Analysis to ensure timely, compliant documentation and regulatory adherence.

Qualifications

• Diploma or higher in a related discipline is preferred.
• Prior-related work experience, ideally in a manufacturing GMP setting.
• Excellent communication and interpersonal skills to interface with all levels of colleagues.

Responsibilities

• Direct and/or lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective and preventative actions.
• Support Engineering documentation review – e.g. electronic logs
• Support Audit Readiness activities
• Support Internal Audit programs
• Collaborate with Engineering colleagues and other departments to maintain compliance posture.
• Comply with Global Policies, Procedures and Guidelines, regulatory requirements and cGMP in day-to-day activities; promote a safe and compliant culture in Carlow.

Skills

Effective communication

Interpersonal skills

Root Cause Analysis

Lean Six Sigma

Regulatory knowledge

Education

Diploma or higher in related discipline

Tools

Microsoft Office

Job description

Tandem Project Management Ltd. seeks an Engineering Compliance Specialist to join the Engineering Department of a biopharmaceutical company in Carlow. You will support GMP and sterile operations, drive deviations and CAPA analytics, and assist with change controls and inspection readiness.

You will author and review controlled documents, collaborate with cross-functional teams, and apply Root Cause Analysis to ensure timely, compliant documentation and regulatory adherence.