Pharma Validation Engineer (Contract) - Sterilization & CQV

PE Global; Carlow; On-site; EUR 83,000 - 124,000; Full time

Job summary

PE Global is seeking a Validation Engineer for a leading pharma client based in Carlow. This contract role focuses on supporting Sterilisation processes, autoclaves and SIP of vessels within a cGMP regulatory framework.

The successful candidate will design, execute and review qualification/validation activities, drive change controls and investigations, and collaborate with Operations, Maintenance and Quality to ensure compliant, robust processes in a fast-paced GMP environment.

Qualifications

• Relevant technical qualification in pharmaceutical/biological/chemical sciences or engineering.
• Knowledge of CTU equipment qualification and thermal mapping.
• Experience leading technical projects in GMP environments.
• Familiarity with DeltaV, Pi System and data monitoring in GMP.

Responsibilities

• Design, author, review and execute qualification/validation documentation and cycle development.
• Execute change controls and investigate deviations.
• Resolve technical issues during studies and executions.
• Engage with Production, Maintenance and Quality during cycle development and PV activities.
• Contribute to quality investigations with technical input.
• Perform root cause analysis of system failures and disturbances.
• Support Lean Six Sigma initiatives and continuous improvement.
• Represent validation on cross-functional projects and at global technical forums.
• Ensure compliance with GMP policies, procedures and guidelines.
• Support regulatory audits and submissions as required.
• Promote a safe, compliant culture in Carlow.

Skills

Validation engineering

Process monitoring

DeltaV automation

PI System

Change control

Lean Six Sigma

cGMP compliance

Thermal mapping

Root cause analysis

Sterile validation

Education

Applied Pharmaceutical/ Biological/ Chemical sciences or Engineering

Tools

CTU qualification

Thermal mapping equipment

Job description

PE Global is seeking a Validation Engineer for a leading pharma client based in Carlow. This contract role focuses on supporting Sterilisation processes, autoclaves and SIP of vessels within a cGMP regulatory framework.

The successful candidate will design, execute and review qualification/validation activities, drive change controls and investigations, and collaborate with Operations, Maintenance and Quality to ensure compliant, robust processes in a fast-paced GMP environment.