Facilities Quality & Operations Engineer – Pharma

About the role

Arcadis is looking for a Facilities Quality & Operations Engineer to support a pharmaceutical site in Ringaskiddy, Co. Cork. The role is a 12‑month contract, with the possibility of extension, and focuses on ensuring facility activities meet GMP and quality standards.

Key responsibilities

• Maintain and update facility‑related GMP documentation (SOPs, work instructions, risk assessments).
• Ensure facilities activities are executed in compliance with GMP and site quality standards.
• Support deviations, CAPAs, and investigations relating to facilities, utilities, and soft services.
• Participate in audits and inspections, ensuring facilities readiness and compliance.
• Act as the primary contact for soft services (cleaning, waste, gowning areas, vendor‑managed activities).
• Coordinate and oversee planned facilities activities to minimise disruption to operations.
• Support vendor management, including performance monitoring and issue resolution.
• Collaborate with internal stakeholders (Ops, QA, EHS, Engineering) to align execution of site services.
• Own and maintain accurate records of facilities activities, ensuring audit readiness.
• Track and trend facilities‑related quality metrics, highlighting risks or recurring issues.
• Drive standardisation of documentation and practices across facilities activities.
• Identify and escalate risks related to facilities operations and compliance.
• Participate in risk assessments (e.g., FMEA) for facilities processes and changes.
• Drive improvements in facilities processes, documentation, and vendor performance.
• Support implementation of best practices across site services and infrastructure.

Required profile

• Bachelor’s degree in Engineering, Quality Management, Life Sciences or a related field.
• 2–4 years’ experience in a regulated environment, preferably pharma/biotech.
• Strong understanding of Quality Management Systems (QMS), GMP, and FDA/EMA regulatory requirements.
• Experience with cross‑functional coordination and vendor management.
• Detail‑oriented with a strong QA mindset.

Required skills

• GMP
• Quality Management Systems (QMS)
• FDA regulations
• EMA regulations
• Risk assessment
• Failure Mode Effects Analysis (FMEA)
• Corrective and Preventive Actions (CAPA)