Validation Compliance Specialist

Next Generation (Ireland); Carlow; On-site; EUR 65,000 - 90,000; Full time

Job summary

Next Generation Recruitment in Carlow is seeking a Validation Compliance Specialist to join a highly regulated pharmaceutical manufacturing environment. You will work on qualification and performance of critical equipment and processes.

You will collaborate with Engineering, Quality and Manufacturing teams on equipment qualification, cleaning validation, sterilisation validation and validation lifecycle activities, supporting audits and regulatory inspections.

Qualifications

• A qualification in Engineering, Science, Pharmaceutical, Biological, Chemical, or a related technical discipline.
• Experience in GMP/cGMP pharmaceutical, biopharmaceutical or regulated manufacturing environments.
• Hands-on experience in validation and equipment qualification.
• Experience with validation studies, including PQ.

Responsibilities

• Deliver validation activities covering equipment, cleaning and sterilisation.
• Plan and execute validation studies, including Performance Qualification (PQ).
• Author and review validation protocols, reports, SOPs and supporting documentation.
• Analyse validation data and document technical findings.
• Support deviations, investigations, risk assessments, CAPAs and root-cause analysis.
• Contribute to periodic validation and revalidation programmes.
• Investigate technical issues and support effective resolution.
• Prepare and maintain documentation for audits and regulatory inspections.
• Collaborate with Engineering, Quality, Manufacturing and other stakeholders to deliver project objectives.

Job description

Take Your Validation Career to the Next Level in Pharmaceutical Manufacturing

Validation Compliance Specialist

This is your chance to join a highly regulated manufacturing environment in Carlow, working on projects that directly support the qualification and performance of critical pharmaceutical equipment and processes.

You’ll work alongside Engineering, Quality and Manufacturing teams across equipment qualification, cleaning validation, sterilisation validation and validation lifecycle activities.

If you’re an experienced Validation Engineer, Validation Specialist, CQV Engineer or Validation/Compliance professional, this role offers the opportunity to broaden your technical experience while contributing to significant pharmaceutical manufacturing projects.

What you’ll be working on

• Deliver validation activities covering equipment, cleaning and sterilisation.


• Plan and execute validation studies, including Performance Qualification (PQ).


• Author and review validation protocols, reports, SOPs and supporting documentation.


• Analyse validation data and document technical findings.


• Support deviations, investigations, risk assessments, CAPAs and root-cause analysis.


• Contribute to periodic validation and revalidation programmes.


• Investigate technical issues and support effective resolution.


• Prepare and maintain documentation for audits and regulatory inspections.


• Collaborate with Engineering, Quality, Manufacturing and other technical stakeholders to deliver project objectives.

What will make you stand out

You’ll ideally bring:

• A qualification in Engineering, Science, Pharmaceutical, Biological, Chemical, or a related technical discipline.


• Previous experience in a GMP/cGMP pharmaceutical, biopharmaceutical or regulated manufacturing environment.


• Hands-on experience in validation and equipment qualification.


• Experience executing Performance Qualification or other validation studies.


• Practical experience with cleaning and/or sterilisation validation.


• Strong technical writing and documentation skills.


• Experience with investigations, deviations, risk assessments, change controls or root-cause analysis.

Additional experience that could give you an edge:

• Sterile fill-finish manufacturing.


• Autoclave, SIP or dry heat sterilisation validation.


• Isolator VHP or HVAC qualification.


• Tank CIP or parts washer validation.


• Cleaning recovery studies using TOC/swab methods.


• Equipment periodic validation and lifecycle management.


• DeltaV, PI System or process monitoring systems.