Pharma Validation Specialist — PQ & Equipment

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

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.