GMP Compliance Engineer - Sterile Manufacturing

Morgan McKinley; Carlow; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory knowledge

Communication skills

Root Cause Analysis

Documentation skills

Time management

Attention to detail

Cross-functional teamwork

Problem solving

Multitasking

Organizational skills

Ausbildung

Diploma or higher

Tools

Microsoft Office

Jobbeschreibung

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.