Validation Engineering Specialist

Ellab; Carlow; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Ellab, a site in Carlow delivering medicines at global scale, is seeking a Validation Engineer to lead compliant, data‑driven qualification and validation across critical systems.

You will plan and oversee periodic revalidation and initial qualification studies, set validation strategies, and coordinate multiple complex projects in a GMP environment, including NPI and process improvements.

Qualifikationen

• 2–3 years pharmaceutical/biotech validation experience
• Working knowledge of regulatory requirements and GMP
• Experience with cleaning validation for reusable parts
• Familiar with process monitoring and automation systems

Aufgaben

• Plan, schedule and oversee periodic revalidation and initial qualification studies.
• Set and deliver validation strategies.
• Lead investigations related to validation and commercial activities.
• Coordinate multiple projects (NPI, process improvements, investigations).
• Execute periodic revalidation, cycle development and initial qualification studies.
• Review and approve validation protocols and reports.
• Author SOPs and technical reports.
• Engage early in projects as a validation SME.
• Act as validation SME on equipment in the assigned area.

Kenntnisse

Validation expertise

GMP knowledge

DeltaV experience

Pi System knowledge

Documentation skills

Project coordination

Ausbildung

Applied Pharmaceutical / Biological / Computer / Chemical sciences or Engineering qualification

Tools

DeltaV

Pi System

Jobbeschreibung

Exciting opportunity for you to join Carlow’s high‑performing manufacturing site to deliver safe, reliable medicines at global scale. We’re hiring a Validation Engineer to lead compliant, data‑driven qualification and validation across critical systems.

What you will do:

• Planning, scheduling and oversight of Periodic Revalidation & Initial Qualification studies.
• Responsible for setting and delivery of validation strategies.
• Lead and supports complex & critical investigations associated with validation and commercial activities.
• Co-ordinate multiple complex projects in parallel including but not limited New Product Introductions, Process Improvements and Investigations.
• Execution of Periodic Revalidation, Cycle Development & Initial Qualification studies as required.
• Technical review and approval of Periodic Revalidation, Cycle Development & Initial Qualification protocols & reports.
• Authoring and reviewing standard operating procedures and technical reports.
• Engage in the early stages of projects.
• Act as validation SME on the equipment within the area assigned

What skills you will need:

In order to excel in this role, you will more than likely have:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
• A minimum of 2-3 years directly related experience in pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• SME in Cleaning Validation for reusable parts and process vessel washing and using Automated COP and CIP systems
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.