Senior Process Engineer: GMP Process Optimization & CI

Morgan McKinley

Tralee

On-site

EUR 65,000 - 90,000

Full time

4 days ago

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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.