Validation Engineer

3 weeks ago

Dublin, Dublin City, Ireland Hero Recruitment Full time

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.

Key Responsibilities

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.
What You Will Need

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.
Desirable Experience

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/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

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