Process Engineer (NPI)

Biotech; Ireland; On-site; EUR 45,000 - 65,000; Full time

Job summary

A leading biotech consultancy is seeking a Process Engineer for its Carlow site. The role involves supporting new product introductions and commercial manufacturing, ensuring compliance with global regulatory standards and promoting a safe work culture. Ideal candidates will have a Bachelor's degree in a relevant field, at least 3 years of manufacturing experience, preferably in a GMP environment, and proficiency in Microsoft Office. This position offers an excellent opportunity for career growth in a dynamic team environment.

Qualifications

• Bachelor’s degree or higher in a science, engineering, or technical discipline.
• At least 3 years of manufacturing experience, preferably in a GMP environment.
• Willingness to support occasional shift work after training.

Responsibilities

• Design, review, and execute qualification and validation documentation and process development studies.
• Develop and implement change controls.
• Support continuous improvement initiatives using Lean Six Sigma methodologies.

Skills

Manufacturing Experience

Technical Project Leadership

Excellent Communication

Education

Bachelor’s degree in Science, Engineering, or Technical Discipline

Tools

Microsoft Office

Automation Systems (DeltaV)

Data Systems (Pi System)

Job description

Job Description

About PSC Biotech

PSC Biotech is a leading biotech consultancy founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US. We serve over 350 clients across more than 23 countries, providing cloud-based software solutions for quality management and regulatory inspections, pharmaceutical contract manufacturing, and metrology services.

Employee Value Proposition

We prioritize our employees by offering career development, training, and mentorship to facilitate growth. Our goal is to create high-performing teams that exceed client expectations in quality, budget, and timelines.

Overview

We are seeking a Process Engineer for our Carlow site to join the Process Engineering Group, reporting to the Technical Engineering Manager. The role involves supporting new product introductions and commercial manufacturing, leading or participating in cross-functional teams, and liaising with vendors and other groups. Prior experience in manufacturing, GMP setting, or technology transfer is preferred. Knowledge of process monitoring, automation systems (DeltaV), and data systems (Pi System) is advantageous but not mandatory.

Responsibilities

• Design, review, and execute qualification and validation documentation and process development studies.
• Develop and implement change controls.
• Contribute to Kaizen events.
• Provide technical input for quality investigations.
• Execute equipment qualification and validation programs, including re-qualification and re-validation.
• Support continuous improvement initiatives using Lean Six Sigma methodologies.
• Perform root cause analysis for system failures or substandard performance.
• Represent technical operations internally and at global forums.
• Ensure compliance with global policies, procedures, regulatory requirements, and cGMP standards.
• Promote a safe and compliant work culture.
• Perform other duties as assigned.

Skills and Qualifications

• Bachelor’s degree or higher in a science, engineering, or technical discipline.
• At least 3 years of manufacturing experience, preferably in a GMP environment.
• Experience leading technical projects.
• Knowledge of process monitoring, automation (DeltaV), and data systems (Pi System) is beneficial.
• Understanding of regulatory standards and equipment validation.
• Experience with sterile filling processes and equipment.
• Proficiency in Microsoft Office and related applications.
• Excellent communication and interpersonal skills.
• Willingness to support occasional shift work after training.