Validation Engineer – GMP Equipment & Sterilization

The Innopharma Group; Ireland; On-site; EUR 70,000 - 100,000; Full time

Job summary

Innopharma Group's Innopharma Technical Services seeks a Validation Engineer to own equipment and cleaning validation within the GMP manufacturing sector in Leinster. The role covers autoclave/SIP sterilisation, cleaning validation, CTU mapping and isolator qualifications, with responsibilities spanning documentation, cycle development, deviations, and regulatory support in a global life sciences context.

The successful candidate will design and execute validation studies, author qualification

Qualifications

• Minimum Level 8 degree in Applied Pharmaceutical / Biological / Chemical sciences or Engineering.
• Proven track record leading technical projects in GMP environments.

Responsibilities

• Design, author, review, approve and execute qualification/validation documentation.
• Resolve technical issues during study execution with Production, Maintenance and Quality.
• Provide input into investigations and perform root cause analysis of system failures.
• Support continuous improvement via Lean Six Sigma and global technical forums.
• Ensure GMP/regulatory compliance and documentation in all activities.
• Assist regulatory audits and submissions as required.

Skills

Equipment validation

Process validation

CTU qualification

Thermal mapping

Data analysis

Sterile fill-finish

DeltaV automation

PI System

GMP knowledge

Regulatory/report writing

Communication

Education

Bachelor-level 8+ degree in relevant technical field

Tools

DeltaV

PI System

Microsoft Office

Job description

Innopharma Group's Innopharma Technical Services seeks a Validation Engineer to own equipment and cleaning validation within the GMP manufacturing sector in Leinster. The role covers autoclave/SIP sterilisation, cleaning validation, CTU mapping and isolator qualifications, with responsibilities spanning documentation, cycle development, deviations, and regulatory support in a global life sciences context.

The successful candidate will design and execute validation studies, author qualification