Impactful Process Validation Engineer (GMP)

PSC Biotech® Corporation; Leinster; On-site; EUR 70,000 - 95,000; Full time

Job summary

PSC Biotech is seeking a Compliance Specialist (Validation) to provide compliance support across validation activities within a cGMP regulatory environment. The role requires coordinating audits, maintaining the Validation Master Plan, and ensuring QMS compliance, with collaboration across regulatory and internal teams.

The successful candidate will bring strong validation expertise, experience with DeltaV and Pi System, and a proactive approach to continuous improvement in a GMP manufacturing

Qualifications

• Relevant technical qualification in Applied Pharmaceutical / Biological or Engineering.
• Experience in GMP manufacturing and deviation management.
• Knowledge of process monitoring systems and DeltaV is a plus.

Responsibilities

• Provide compliance support for validation activities.
• Support regulatory audits and internal audits.
• Maintain the Validation Master Plan and annual reviews.
• Ensure compliance with QMS and GMP regulations.
• Coordinate validation documentation and change control.

Skills

GMP manufacturing

Validation

Documentation

Risk assessments

Change control

Audit support

QMS compliance

Airflow?

Education

Applied Pharmaceutical

Engineering qualification

Tools

DeltaV

Pi System

Microsoft Office

Job description

PSC Biotech is seeking a Compliance Specialist (Validation) to provide compliance support across validation activities within a cGMP regulatory environment. The role requires coordinating audits, maintaining the Validation Master Plan, and ensuring QMS compliance, with collaboration across regulatory and internal teams.

The successful candidate will bring strong validation expertise, experience with DeltaV and Pi System, and a proactive approach to continuous improvement in a GMP manufacturing