Validation Compliance Specialist

Next Generation; Carlow; On-site; EUR 52,000 - 70,000; Full time

Job summary

Next Generation Recruitment is seeking a Validation Compliance Specialist for a highly regulated pharmaceutical manufacturing environment in Carlow. You'll join cross-functional teams to support qualification and performance validation of critical equipment and processes.

The role covers equipment, cleaning and sterilisation validation, PQ studies, and authoring validation protocols, reports and SOPs. Strong writing, GMP knowledge and problem-solving will help you thrive in this challenge.

Qualifications

• Experience in GMP/cGMP pharmaceutical environments.
• Hands-on validation and equipment qualification experience.
• Strong technical writing and documentation skills.
• Experience with deviations, investigations, risk assessments or CAPAs.

Responsibilities

• Deliver validation activities covering equipment, cleaning and sterilisation.
• Plan and execute validation studies including 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.
• Prepare documentation for audits and regulatory inspections.

Skills

Validation

GMP / cGMP

Equipment qualification

Technical writing

Root-cause analysis

Cross-functional collaboration

Education

Engineering/Science/Pharmaceutical background

Tools

DeltaV

PI System

TOC / Swab methods

SIP / Autoclave validation

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 pharmaceutical manufacturing environment in Cardlow, working on projects that directly support the qualification and performance of critical 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‑causal 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.

Ready for your next move?

If you’re an experienced validation professional looking for your next challenge in pharmaceutical manufacturing, we’d love to hear from you.

All applications are treated in the strictest confidence.

Next Generation Recruitment specialises in Supply Chain, Procurement, Engineering, Quality, Technical, Scientific, Manufacturing, and Operations recruitment across permanent, contract, and temporary positions.

Your personal data will never be shared outside our organisation without your prior written consent.