Validation Engineer

Validation Engineer - Exciting Opportunity in Carlow, Ireland

Job Type: Contract
Location: Carlow, Ireland
Industry: Pharmaceutical / Biotechnology / cGMP Regulatory Environment

We are currently seeking a passionate and driven Validation Engineer to join a team committed to ensuring the highest standards of quality and compliance in a cGMP manufacturing environment. This is an excellent opportunity for professionals with experience in validation to enhance their career while working on cutting-edge technology in the heart of Ireland.

As a Validation Engineer, you will play a key role in ensuring validation and qualification activities are performed to the highest standards. Your responsibilities will include, but are not limited to:

• Design & Documentation: Author, review, approve, and execute qualification/validation documentation and cycle development studies, ensuring compliance with cGMP and regulatory standards.
• Change Control Management: Oversee the development and execution of change controls, ensuring that any modifications meet the required standards and are validated appropriately.
• Technical Troubleshooting: Resolve any technical issues that arise during the execution of validation studies, using root cause analysis to find and address system failures.
• Collaboration: Work closely with cross-functional teams, including Production, Maintenance, and Quality, to ensure seamless execution of cycle development and performance qualification activities.
• Compliance & Audits: Play an active role in maintaining compliance with global policies, GMP guidelines, and regulatory requirements, while supporting audits and inspections as required.
• Continuous Improvement: Drive continuous improvement initiatives through Lean Six Sigma methodologies, contributing to the enhancement of processes and systems.

To succeed in this role, you should possess a strong technical background and relevant experience in the pharmaceutical or biotechnology sectors. The ideal candidate will have:

• Education: A relevant Level 8 technical qualification in Pharmaceutical, Biological, Chemical sciences, or Engineering.
• Experience: A proven track record in validation and qualification within a GMP environment, with hands-on experience in a similar role.
• Key Skills:
  • Extensive knowledge of equipment validation, process validation, and sterilisation technologies.
  • Experience with CTU equipment qualification and thermal mapping.
  • Strong technical troubleshooting abilities, especially in resolving deviations and exceptions.
  • Familiarity with automation systems (e.g., DeltaV, Pi System) would be an advantage.
  • Excellent proficiency in Microsoft Office and related software applications.
  • Project management skills and the ability to lead technical projects.
  • A solid understanding of regulatory requirements and GMP guidelines.
• Personal Attributes: Strong communication skills, with the ability to engage with cross-functional teams and external stakeholders. A collaborative mindset and ability to work both independently and within teams are essential.

In addition to the core qualifications, the following experience will be beneficial:

• Sterile Fill-Finish processes and associated equipment.
• Filter Validation and Container Closure Integrity.
• Autoclave/SIP Sterilisation Validation.
• Isolator Qualification (Filling, Sterility, Material Transfer).
• Temperature Mapping and Cleaning Validation.
• Project Management Certification.

For further information on this role please contact Róisín Vaughan on 086 440 3742 / consult@hero.ie

Check out all our open jobs on our HERO Recruitment website –https://www.hero.ie/

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