Commissioning & Qualification Engineer – III based in Ballydine

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

Commissioning & Qualification Engineer

Join a dynamic team as a Commissioning & Qualification Engineer,where you will play a pivotal role in ensuring the success of complex pharmaceutical and biotech projects. This is an exciting opportunity for a highly skilled professional to contribute to cutting‑edge processes in a fast‑paced, GMP environment. If you thrive on delivering technical excellence and driving process improvements, this role is your next career move.

What you’ll do:

You will be responsible for commissioning and qualifying critical process and laboratory equipment, designing and executing process validation studies for large‑scale API processes, and assessing change control impacts to ensure ongoing validation. You will apply Lean Six Sigma methodologies to enhance efficiency, streamline operations, and support technology transfer, new product introductions, and other strategic initiatives. Your expertise will be essential in reviewing technical documentation, CAPAs, deviations, and metrics, contributing to continuous improvement in a collaborative, site‑based setting.

Required Skills and 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

Nice to Have Skills:

• Experience in pharmaceutical or biotech sterile manufacturing environments
• Background in process validation studies
• Familiarity with Lean Six Sigma tools and methodologies
• Previous experience working with vendors or multiple MSD sites

Preferred Education and Experience:

• Degree in Mechanical or Chemical Engineering
• Extensive experience in GMP regulated industries, particularly in pharma or biotech sectors