NPI Process Engineer: Lean, Validation & GMP

Tandem Project Management Ltd.; Carlow; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

A biopharmaceutical company in Carlow is seeking a Process Engineer to provide technical support for new product introductions and manufacturing operations. The successful candidate will ensure compliance with regulatory standards and contribute to process improvements through Lean Six Sigma methodologies. Candidates should have a relevant Bachelor's degree and at least 3 years of experience in a manufacturing environment. The role offers hybrid working after training completion.

Qualifications

• Minimum 3 years’ experience in a manufacturing environment, preferably GMP.
• Experience in leading technical-related projects.
• Knowledge of regulatory requirements for Ireland and international standards.

Responsibilities

• Design, review, and approve qualification documentation.
• Support continuous improvement efforts.
• Perform root cause analysis on system failures.

Skills

Technical project leadership

Process monitoring systems

Root cause analysis

Lean Six Sigma methodologies

Equipment validation

GMP compliance

Effective communication

Education

Bachelor’s Degree in Science or Engineering

Tools

Microsoft Office

DeltaV

Pi System

Job description

A biopharmaceutical company in Carlow is seeking a Process Engineer to provide technical support for new product introductions and manufacturing operations. The successful candidate will ensure compliance with regulatory standards and contribute to process improvements through Lean Six Sigma methodologies. Candidates should have a relevant Bachelor's degree and at least 3 years of experience in a manufacturing environment. The role offers hybrid working after training completion.