Pharma GMP Project Engineer - Process & Equipment Lead

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

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.