Project Engineer

Sterling Engineering Ltd - Ireland & Europe; Sligo; On-site; EUR 75,000 - 110,000; Full time

Job summary

Sterling Engineering Ltd - Ireland & Europe in Ireland is seeking a Project Engineer to provide engineering support to maximise availability, reliability and performance of site process equipment and utilities. You will manage capital projects up to €5 million, while supporting continuous improvement and process safety initiatives.

You will work with Production, Engineering, Quality, Operations, and external partners to ensure safely delivered projects on schedule, within budget and to GMP

Qualifications

• Degree in Mechanical, Chemical, Process or related Engineering.
• 5+ years’ pharmaceutical manufacturing/site engineering experience.
• Strong OSD and/or API manufacturing experience.
• Proven delivery of capital projects from cradle to handover.
• Experience with equipment specification, installation, commissioning and qualification.
• Strong C&Q, change control, cGMP and project management knowledge.
• Experience with batch processing, utilities, facilities and manufacturing systems.
• Strong troubleshooting and contractor management skills.

Responsibilities

• Manage pharmaceutical capital projects from concept through design, procurement, installation, C&Q and handover.
• Develop scopes, feasibility studies, budgets, estimates and project plans.
• Specify, install and commission process equipment, facilities and utilities.
• Lead C&Q, cleanroom, HVAC, CIP, clean/black utilities and manufacturing equipment activities.
• Provide process engineering, troubleshooting and technical support in a live GMP environment.
• Drive equipment reliability, continuous improvement and process efficiency.
• Manage contractors, suppliers and external engineering teams.
• Support change controls, process safety initiatives and site projects.
• Ensure compliance with cGMP, regulatory, quality and safety requirements.

Skills

Project management

Process engineering

Troubleshooting

Contractor management

C&Q

Regulatory compliance

Education

Mechanical, Chemical, or Process Engineering degree

Tools

DeltaV

Job description

As Project Engineer, you will provide engineering support to maximise the availability, reliability and performance of site process equipment and utilities. You will manage and deliver capital engineering projects, typically up to approximately €5 million, while supporting continuous improvement, process engineering, troubleshooting and process safety initiatives across the site.

You will work closely with Production, Engineering, Quality, Operations, contractors and external engineering partners to ensure projects and improvements are delivered safely, on schedule, within budget and to the required GMP and quality standards.

Key Responsibilities

• Manage pharmaceutical capital projects from concept through design, procurement, installation, C&Q and handover.
• Develop scopes, feasibility studies, budgets, estimates and project plans.
• Specify, install and commission process equipment, facilities and utilities.
• Lead C&Q, cleanroom, HVAC, CIP, clean/black utilities and manufacturing equipment activities.
• Provide process engineering, troubleshooting and technical support in a live GMP environment.
• Drive equipment reliability, continuous improvement and process efficiency.
• Manage contractors, suppliers and external engineering teams.
• Support change controls, process safety initiatives and site projects.
• Ensure compliance with cGMP, regulatory, quality and safety requirements.

Essential Experience

• Degree in Mechanical, Chemical, Process or related Engineering.
• 5+ years’ pharmaceutical manufacturing/site engineering experience.
• Strong OSD and/or API manufacturing experience.
• Proven delivery of capital projects from cradle to handover.
• Experience with equipment specification, installation, commissioning and qualification.
• Strong C&Q, change control, cGMP and project management knowledge.
• Experience with batch processing, utilities, facilities and manufacturing systems.
• Strong troubleshooting and contractor management skills.

Technical Experience

• OSD/API equipment and manufacturing systems.
• Facilities, cleanrooms, HVAC, CIP and utilities.
• Containment/downflow booths.
• Automation and controls, ideally DeltaV.
• Pharmaceutical process equipment and infrastructure.

Desirable

• TrackWise, electrical engineering, ATEX and process safety experience.
• Equipment reliability and continuous improvement experience.