Project Engineer

CREGG; Connacht; On-site; Confidential; Full time

Job summary

CREGG in Mayo seeks an experienced Project Engineer for a GMP-regulated manufacturing environment. You will lead engineering projects from concept through installation, commissioning and validation, collaborating with production, QA, validation and external suppliers to ensure compliant, timely delivery.

The role requires strong technical problem-solving, hands-on process development and scale-up experience, with a focus on quality and regulatory standards.

Qualifications

• 4+ years in project/maintenance engineering within GMP manufacturing.
• Experience in pharma, medical device, or food manufacturing is required.
• Proven track record of engineering project management and equipment installation/qualification.
• Hands-on experience with process development and optimization.
• Experience executing IQ/OQ/PQ validation activities.
• Knowledge of GMP, quality systems, risk assessments and change control processes.
• Experience working with cross-functional teams and external contractors or suppliers.
• Strong technical problem-solving, organizational, and project management skills.
• Excellent communication and documentation skills for handling multiple projects.

Responsibilities

• Lead and coordinate engineering projects from concept to installation, commissioning, qualification, and handover.
• Manage equipment installation, commissioning and qualification in a GMP environment.
• Develop and implement process improvements to increase efficiency, quality, equipment performance and reliability.
• Plan, execute and support process and equipment validation activities (IQ, OQ, PQ).
• Support development, optimization and scale-up of manufacturing processes to meet quality and production needs.
• Work on projects involving liquid products and fill-finish processes where applicable.
• Prepare and review engineering docs, validation protocols, technical reports, risk assessments and SOPs.
• Collaborate with QA, Production, Process Development and Validation teams to meet milestones.
• Coordinate external contractors and suppliers to ensure on-time, on-budget project delivery.
• Support equipment upgrades, new equipment introductions and technology transfers.
• Manage project schedules, resources, budgets and deliverables; provide progress updates.
• Ensure project documentation, change controls and validation records are maintained per site procedures.

Skills

Project engineering

GMP

Equipment installation

Process development

Process validation

IQ/OQ/PQ

Cross-functional teamwork

Documentation

Supplier management

Process scale-up

Job description

Project Engineer - Mayo

Industry: Pharmaceutical Manufacturing

Job Overview

We are seeking an experienced Project Engineer to join a GMP-regulated manufacturing environment, with responsibility engineering projects, process development, equipment installation, commissioning, and qualification activities.

Experience within a pharmaceutical, medical device, or food manufacturing environment, with a strong understanding of GMP requirements, process and equipment validation, and project execution. Experience working with pharmaceutical liquid/Powder products and fill-finish manufacturing processes would be highly advantageous.

This role will involve working cross-functionally with engineering, production, quality, validation, and external suppliers to deliver projects safely, efficiently, and in compliance with regulatory and quality standards. strong technical and project delivery experience in a regulated manufacturing environment. They will be comfortable managing projects from development through to equipment qualification and process validation, working closely with multidisciplinary teams to ensure successful implementation

Key Responsibilities

• Lead and coordinate engineering projects from initial concept and process development through to installation, commissioning, qualification, and handover.
• Manage equipment installation, commissioning, and qualification activities within a GMP-regulated manufacturing environment.
• Develop and implement process improvements to enhance manufacturing efficiency, product quality, equipment performance, and operational reliability.
• Plan, execute, and support process and equipment validation activities, including IQ, OQ, and PQ protocols.
• Support the development, optimization, and scale-up of manufacturing processes, ensuring they meet quality, safety, and production requirements.
• Work on projects involving pharmaceutical liquid products and fill-finish manufacturing processes, where applicable.
• Prepare and review engineering documentation, validation protocols, technical reports, risk assessments, and standard operating procedures (SOPs).
• Collaborate with Quality Assurance, Production, Process Development, and Validation teams to deliver project milestones.
• Coordinate external contractors, equipment vendors, and suppliers to ensure projects are delivered on time and within budget.
• Support equipment upgrades, new equipment introductions, process transfers, and continuous improvement initiatives.
• Manage project schedules, resources, budgets, and technical deliverables, providing regular progress updates to relevant stakeholders.
• Ensure project documentation, change controls, and validation records are completed accurately and maintained in accordance with site procedures.

Requirements

• 4+ years' project engineering/mechanical engineering experience within a GMP-regulated manufacturing environment.
• Experience in pharmaceutical, medical device, or food manufacturing.
• Proven experience in engineering project management, equipment installation, commissioning, and qualification.
• Practical experience in process development and process optimization.
• Experience executing process and equipment validation activities, including IQ, OQ, and PQ.
• Knowledge of GMP requirements, quality systems, risk assessments, and change control processes.
• Experience working with cross-functional teams and managing external contractors or equipment suppliers.
• Strong technical problem-solving, organizational, and project management skills.
• Excellent communication and documentation skills, with the ability to manage multiple projects and competing priorities.
• Experience with new equipment introduction, process scale-up, and manufacturing technology transfers.

NB: Candidates must be located in Ireland with full Irish work authorisation.