Senior Process Engineer

Morgan McKinley; Tralee; On-site; EUR 65,000 - 90,000; Full time

Job summary

Morgan McKinley is seeking a high-caliber Process Engineer to join a leading global pharmaceutical organization in Tralee, Ireland. You will provide critical technical expertise to operations, driving equipment efficiency, and ensuring strict GMP data integrity and regulatory compliance on site.

You will lead CAPA investigations, support project delivery from design through commissioning, and champion continuous improvement initiatives across the manufacturing process, including energy savings

Qualifications

• B.S. in Chemical, Biochemical, or Process Engineering (or equivalent industrial experience).
• Proven track record in a cGMP manufacturing environment, with strong filtration, purification, equipment qualification, and process validation knowledge.
• Hands-on experience with process control systems, instrumentation, and independent project delivery.
• Lean Six Sigma Yellow Belt as a minimum certification.

Responsibilities

• Technical Oversight & Troubleshooting: provide engineering support to operations; lead root-cause analysis and CAPA for process equipment issues.
• Automation & Data Integrity: manage DCS and process control systems, ensuring performance, compliance, and GMP data integrity.
• Continuous Improvement: lead Lean Six Sigma initiatives focused on process optimization, waste reduction, and energy savings.
• Project & Tech Transfer: progress engineering projects from design to commissioning and support transfer of new technologies.
• Compliance: ensure operations align with cGMP, ISO 14001, EMAS, and health, safety, and environmental legislation.

Skills

Process Engineering

cGMP manufacturing

Lean Six Sigma

DCS

PLC

Instrumentation

CAPA

Education

Bachelor's degree in Chemical, Biochemical, or Process Engineering

Tools

DCS

PLC

Job description

The Opportunity

We are seeking a high-caliber Process Engineer to join a leading global pharmaceutical organization. In this dynamic role, you will provide critical technical expertise to the Operations department, driving equipment efficiency, resolving complex technical challenges, and ensuring strict adherence to manufacturing schedules. You will be a key player in maintaining robust regulatory compliance while championing continuous improvement on site.

Key Responsibilities

• Technical Oversight & Troubleshooting: Provide engineering support to operational areas; lead root-cause analysis and execute corrective/preventative actions (CAPA) for process equipment issues.
• Automation & Data Integrity: Manage and optimize DCS and other process control systems, ensuring high performance, system compliance, and strict GMP data integrity.
• Continuous Improvement: Lead Lean Six Sigma initiatives and continuous improvement (CI) forums focused on process optimization, waste reduction, and energy savings.
• Project & Tech Transfer: Progress engineering projects independently- from design through to commissioning- and support the transfer of new technologies and processes.
• Compliance: Ensure all operations strictly align with cGMP, ISO 14001, EMAS, and health, safety, and environmental legislation.

Qualifications & Experience

Essential

• Education: B.S. in Chemical, Biochemical, or Process Engineering (or equivalent industrial experience).
• Expertise: Proven track record in a cGMP manufacturing environment, with a strong understanding of filtration, purification, equipment qualification, and process validation.
• Technical Skills: Hands-on experience with process control systems, instrumentation, and independent project delivery.
• Problem Solving: Strong analytical mindset with a minimum of a Lean Six Sigma Yellow Belt.

Preferred

• Direct experience in drug manufacturing or a cGMP start-up environment.
• Advanced proficiency with control systems (DCS, PLC).