Senior Commissioning & Qualification Engineer (GMP)

Planet Pharma; Ireland; On-site; EUR 90,000 - 120,000; Full time

Job summary

Planet Pharma is seeking a Commissioning & Qualification Engineer to join its GMP-focused team in Ireland. You will lead commissioning and qualification activities for complex process and laboratory equipment, and design and execute validation studies for large-scale API processes.

You will assess change controls, apply Lean Six Sigma to drive efficiency, support technology transfer and new product introductions, and review documentation, CAPAs, deviations and metrics in a collaborative,

Qualifications

• BS in Mechanical, Chemical Engineering or related technical field.
• Completed DeltaV training.
• Minimum of 5 years of DeltaV application experience.
• At least 3 years of site-based commissioning in a GMP environment.
• Proven track record in commissioning and qualification of complex systems on capital projects.
• Solid understanding of cGMPs, SDLC methodologies, and validation principles.
• Excellent facilitation, problem-solving, and decision-making skills.
• Ability to work effectively in cross-functional teams.

Responsibilities

• Commission and qualify critical process and laboratory equipment.
• Design and execute process validation studies for large-scale API processes.
• Assess change control impacts to ensure ongoing validation.
• Apply Lean Six Sigma methodologies to enhance efficiency, streamline operations, and support technology transfer, new product introductions, and other strategic initiatives.
• Review technical documentation, CAPAs, deviations, and metrics, contributing to continuous improvement in a collaborative, site-based setting.

Skills

Cross-functional teamwork

Problem-solving

Facilitation

Decision-making

Education

BS in Mechanical, Chemical Engineering, or related technical field

Tools

DeltaV

Job description

Planet Pharma is seeking a Commissioning & Qualification Engineer to join its GMP-focused team in Ireland. You will lead commissioning and qualification activities for complex process and laboratory equipment, and design and execute validation studies for large-scale API processes.

You will assess change controls, apply Lean Six Sigma to drive efficiency, support technology transfer and new product introductions, and review documentation, CAPAs, deviations and metrics in a collaborative,