GMP Compliance Engineer - Biotech Manufacturing

PE Global; Carlow; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Communication skills

Team collaboration

Root Cause Analysis

Attention to detail

Time management

Problem solving

Lean Six Sigma

Regulatory knowledge

Ausbildung

Diploma or higher

Tools

Microsoft Office

Electronic documentation systems

Jobbeschreibung

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.