Senior Process Engineer

Morgan McKinley; Tralee; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Morgan McKinley is seeking a Process Engineer for a leading global pharmaceutical organization in Ireland. You will provide critical technical expertise to Operations, drive equipment efficiency, resolve complex technical challenges, and maintain manufacturing schedules.

You will lead root-cause analysis, manage DCS and other control systems to ensure GMP data integrity, and champion continuous improvement and tech transfer while complying with cGMP, ISO 14001, EMAS, and safety regulations.

Qualifications

• Education and a relevant engineering degree are required.
• Proven track record in a cGMP manufacturing environment.
• Hands-on experience with process control systems and instrumentation.
• Lean Six Sigma Yellow Belt certification or equivalent problem-solving approach.

Responsabilités

• Technical oversight & troubleshooting of process equipment in operations.
• Manage DCS and other control systems to ensure GMP data integrity.
• Lead Lean Six Sigma and CI initiatives for process optimization and energy savings.
• Progress projects from design through commissioning and tech transfer.
• Ensure compliance with cGMP, ISO 14001, EMAS, and safety regulations.

Connaissances

cGMP manufacturing

Filtration

Purification

Equipment qualification

Process validation

Process control systems

Instrumentation

Lean Six Sigma Yellow Belt

Formation

B.S. in Chemical Engineering, Biochemical Engineering, or Process Engineering

Outils

DCS

PLC

Description du poste

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).