Process Validation Engineer

Process Validation Engineer, CPV/MSA

Location: Waterford | Contract: 12 months

A global biopharmaceutical company based in Waterford is seeking a Process Validation Engineer to support its Continued Process Verification and MSAT activities.

This contract position would suit a candidate with approximately five years’ experience in process validation, CPV or Manufacturing Science and Technology within a GMP-regulated pharmaceutical or biopharmaceutical environment.

The Position

You will support the site MSAT lead in developing and implementing the site’s Continued Process Verification strategy in line with global guidance.

Responsibilities will include:

• Supporting the development of the site CPV strategy and associated CPV plans.
• Reviewing current CPV practices and supporting the remediation of identified gaps.
• Conducting statistical analysis and monitoring manufacturing process performance.
• Supporting process confirmation activities and KPI monitoring.
• Working closely with Production, Quality Control, Quality and Data Science teams.
• Preparing and maintaining controlled GMP documentation.

• Approximately five years’ relevant industry experience.
• Strong experience in process validation and Continued Process Verification.
• MSAT or manufacturing process support experience.
• Experience within pharmaceutical, biopharmaceutical or biotech manufacturing.
• Statistical analysis and process-monitoring capability.
• Strong knowledge of GMP manufacturing and controlled documentation.
• Sentinel experience would be an advantage.

The role is currently fully site-based in Waterford, five days per week.

Interested? Apply now or contact Kerry Rickard for further information.