An exciting opportunity is available for an experienced Isolator Validation Engineer to join a high-performing team in a dynamic cGMP regulatory environment. This role focuses on the qualification of isolator systems, including Airflow Visualisation, Vaporised Hydrogen Peroxide (VHP), and HVAC components.

Key Responsibilities:

As an Isolator Validation Engineer, you will:

• Design, author, review, approve, and execute qualification and validation documentation.
• Develop and execute cycle development studies in alignment with internal approval processes.
• Support and manage change control documentation and execution.
• Troubleshoot and resolve technical issues during validation studies.
• Collaborate closely with Production, Maintenance, and Quality teams during validation activities.
• Provide technical input into deviations and quality investigations.
• Conduct root cause analysis using standard tools and methodologies.
• Apply Lean Six Sigma principles to drive continuous improvement.
• Represent the validation team in cross-functional projects and global forums.
• Ensure compliance with all regulatory requirements, GMP standards, and company procedures.
• Complete risk assessments, address corrective actions, and support inspections and audits.
• Contribute to a culture of safety, compliance, and performance.
• Perform additional duties as required.

Required Experience & Skills:

To succeed in this role, you should have:

• Direct experience with Isolator Airflow Visualisation, VHP, and HVAC Qualification.
• Solid background in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Experience in writing and executing validation protocols, reports, and change controls.
• Proven ability to lead validation efforts independently and as part of a team.
• Knowledge of deviation management and CAPA processes.
• Understanding of regulatory standards applicable in Ireland, the EU, and internationally.
• Strong analytical skills, with the ability to interpret complex data and identify trends.
• Proficiency in Microsoft Office and relevant job-related applications.
• Excellent communication, collaboration, and documentation skills.

Preferred Qualifications & Skills:

The following additional experience is advantageous but not necessary:

• Filter Validation
• Container Closure Integrity (CCI) Qualification
• Shipping Qualification
• Equipment Lifecycle Validation
• Autoclave / SIP Sterilisation Validation
• Dry Heat Sterilisation
• Cleaning Validation
• Controlled Temperature Equipment Qualification
• Vial and Syringe Processing Technologies
• Knowledge of DeltaV, Pi System, or other automation/data systems
• Project Management skills or certification

Education & Qualifications:

• A relevant technical qualification in Applied Pharmaceutical, Biological, or Chemical Sciences, or Engineering.

Apply today!

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters
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 - HERO Recruitment: Leading STEM Recruitment Agency 

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.