Project Engineer; Capex

Our client, a leading biopharmaceutical company in Waterford, is seeking a Project Engineer (GMP & Cleanroom Construction) to join their Project Engineering team. The successful candidate will be responsible for delivering GMP facility upgrades and cleanroom construction projects within a highly regulated manufacturing environment. This role will oversee all aspects of project delivery, including scope, schedule, cost, safety, quality and regulatory compliance, while providing technical expertise in GMP facilities, cleanroom design, construction, commissioning and qualification.

The position offers the opportunity to work across multidisciplinary projects supporting manufacturing operations and site expansion.

• Manage the delivery of engineering projects from concept through to completion, ensuring projects are delivered safely, on time, within budget and in compliance with GMP requirements.
• Lead project planning, scheduling, cost control, risk management and project reporting activities.
• Coordinate multidisciplinary project teams, contractors and stakeholders throughout all phases of project delivery.
• Manage design reviews and ensure compliance with project scope, user requirements and engineering standards.
• Oversee contractor performance, ensuring works are completed safely, efficiently and to the required quality standards.
• Support tendering activities and coordinate engineering documentation through document management systems.
• Act as the technical lead for GMP facility upgrades and cleanroom construction projects.
• Ensure compliance with EU GMP requirements, aseptic processing principles and regulatory expectations throughout project execution.
• Coordinate cleanroom qualification activities, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Review engineering designs relating to cleanroom layouts, HVAC systems, pressure cascades, airlocks and personnel/material flows.
• Work closely with Engineering, Manufacturing, Quality Assurance, Validation and Commissioning teams to ensure successful project delivery.
• Support commissioning, qualification and validation activities for facilities and equipment.
• Develop and maintain project schedules, identifying risks and implementing corrective actions where required.
• Manage project scope, budgets and change control processes, ensuring all variations are appropriately documented and approved.
• Ensure all construction activities are carried out in accordance with Health & Safety requirements, Safe Systems of Work and approved RAMS.
• Coordinate deviation management, CAPAs, validation documentation and qualification records in line with GMP requirements.
• Support regulatory inspection readiness and audit preparation activities.
• Maintain project documentation, including specifications, RFIs, submittals, qualification documentation and project deliverables.
• Coordinate with CQV teams during equipment and facility qualification activities.
• Monitor project progress and resource requirements, escalating issues where necessary.

• Degree in Mechanical, Chemical, Process or related Engineering discipline, or equivalent qualification.
• 5–10 years' experience delivering engineering projects within pharmaceutical or biotechnology GMP environments.
• Proven experience managing GMP facility upgrades, cleanroom construction, commissioning and qualification activities.
• Strong understanding of GMP, GDP and pharmaceutical regulatory requirements.
• Experience supporting Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Knowledge of cleanroom design principles, contamination control strategies and cleanroom classification standards (ISO 14644 and EU GMP).
• Experience supporting validation activities, including equipment qualification and cleaning validation.
• Working knowledge of HVAC systems, pressure cascades and environmental monitoring requirements.
• Experience managing contractors and coordinating multidisciplinary project teams.
• Strong project planning, scheduling, budgeting and risk management skills.
• Excellent communication, organisation and stakeholder management skills.
• Proficient in Microsoft Office applications and project management software.
• Experience supporting regulatory inspections and audits would be advantageous.