GMP Project Engineer: Pharma Process & Equipment

CREGG; Connacht; Sur place; Confidential; Plein temps

Résumé du poste

CREGG is seeking an experienced Project Engineer for a GMP-regulated manufacturing environment in Ireland (Connacht). The role covers responsibility engineering projects, process development, equipment installation, commissioning and qualification activities.

You will work across engineering, production, quality, validation and with external suppliers to deliver compliant projects on time. The ideal candidate brings 4+ years in project/ mechanical engineering within GMP settings, with

Qualifications

• 4+ years' project/ mechanical engineering experience in a GMP-regulated manufacturing environment.
• Experience in pharmaceutical, medical device, or food manufacturing.
• Proven experience in engineering project management, equipment installation, commissioning and qualification.
• Experience with IQ, OQ and PQ validation activities.
• 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.

Responsabilités

• Lead and coordinate engineering projects from concept through installation, commissioning, qualification and handover.
• Manage equipment installation, commissioning and qualification activities in a GMP manufacturing environment.
• Develop and implement process improvements to enhance manufacturing efficiency, product 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 ensuring quality, safety and production requirements.
• Work on projects involving pharmaceutical liquid products and fill-finish processes where applicable.
• Prepare and review engineering documentation, validation protocols, technical reports, risk assessments and SOPs.
• Collaborate with QA, Production, Process Development and Validation teams to hit milestones.
• Coordinate external contractors, equipment vendors and suppliers to deliver on time and within budget.
• Support equipment upgrades, new equipment introductions, process transfers and continuous improvement initiatives.
• Manage project schedules, resources, budgets and deliverables with regular updates to stakeholders.
• Ensure project documentation, change controls and validation records are maintained per site procedures.

Connaissances

GMP knowledge

Project management

Cross-functional collaboration

Documentation skills

Risk assessments

Problem solving

Description du poste

CREGG is seeking an experienced Project Engineer for a GMP-regulated manufacturing environment in Ireland (Connacht). The role covers responsibility engineering projects, process development, equipment installation, commissioning and qualification activities.

You will work across engineering, production, quality, validation and with external suppliers to deliver compliant projects on time. The ideal candidate brings 4+ years in project/ mechanical engineering within GMP settings, with