Validation Engineer

Title: Validation Engineer

Location: Westport

Type: 12-Month Contract

Salary: €50 - €60 per hour

Ref: DES - 1214

The Validation Engineer is responsible for supporting the qualification and validation of cGMP equipment, systems, and processes used in manufacturing operations. This role ensures all validation and revalidation activities are completed in line with regulatory standards (e.g. FDA, HPRA) and internal quality requirements, while supporting project delivery and compliance across the site.

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• Support and execute the site Validation Master Plan across new and existing processes and equipment.
  
• Coordinate and perform validation activities (IQ/OQ/PQ) in line with regulatory and corporate standards.
  
• Prepare, review, and manage validation documentation to ensure timely completion and compliance.
  
• Collaborate with cross-functional teams to deliver validation projects and resolve issues.
  
• Participate in risk assessments and design review processes.
  
• Track and report on validation metrics and project progress.
  
• Support Product Quality Reviews (PQR) and laboratory equipment reviews as required.
  
• Stay up to date with regulatory requirements and provide support during audits.
  
• Participate in internal and external audits, including preparation and response activities.
  
• Support EHS, quality, and continuous improvement initiatives.
  

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• Bachelor’s degree in Engineering, Science, or a related discipline.
  
• 2–3 years’ experience in pharmaceutical or medical device industry.
  
• Strong knowledge of GMP and regulatory requirements.
  
• Hands‑on experience with validation activities (IQ/OQ/PQ).
  
• Experience in equipment, sterilisation, facility, or aseptic validation is highly desirable.
  
• Excellent project management and organizational skills.
  
• Strong problem‑solving and critical thinking abilities.
  
• Proficient in Microsoft Office (Word, Excel).
  
• Strong communication and stakeholder management skills. xcfaprz
  

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• 100% onsite during initial onboarding/training period
  
• Hybrid thereafter (3 days onsite)
  

*Only candidates with a valid work visa for Ireland or an EU passport will be considered.