Project Engineer TPM6032

Tandem Project Management Ltd.; Dublin; Hybrid; EUR 70,000 - 110,000; Full time

Job summary

Tandem Project Management Ltd. is seeking a Project Engineer (GMP & Cleanroom Construction) to deliver GMP facility upgrades and cleanroom construction projects within a highly regulated manufacturing environment in Ireland.

The role covers scope, schedule, cost, safety, quality and regulatory compliance, with technical leadership in GMP facilities, cleanroom design, construction, commissioning and qualification.

Qualifications

• 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.
• Experience delivering GMP facility upgrades, cleanroom construction, commissioning and qualification activities.
• Strong understanding of GMP, GDP and pharmaceutical regulatory requirements.
• Experience supporting DQ, IQ, OQ and PQ.
• Knowledge of cleanroom design principles, contamination control strategies and ISO 14644/EU GMP.

Responsibilities

• Manage delivery of engineering projects from concept to completion, safely, on time and within budget with GMP compliance.
• Lead project planning, scheduling, cost control, risk management and reporting.
• Coordinate multidisciplinary project teams, contractors and stakeholders through all phases.
• Oversee design reviews and ensure compliance with scope, user requirements and engineering standards.
• Support tendering activities and coordinate documentation through document management systems.
• Act as technical lead for GMP facility upgrades and cleanroom construction projects.
• Coordinate cleanroom qualification activities: DQ, IQ, OQ, PQ.
• Ensure regulatory inspections readiness and audit preparation activities.
• Maintain project documentation including specifications, RFIs, submittals and deliverables.

Job description

Summary:

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.

Responsibilities:

• 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, riskmanagementand project reporting activities.
• Coordinate multidisciplinary project teams, contractorsand stakeholders throughout all phases of project delivery.
• Manage design reviews and ensure compliance with project scope, userrequirementsand 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 processingprinciplesand 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,airlocksand 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 andmaintainproject schedules,identifyingrisks and implementing corrective actions whererequired.
• Manage project scope,budgetsand change control processes, ensuring all variations are appropriately documented and approved.
• Ensure all construction activities are carried outin accordance withHealth & 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, qualificationdocumentationand project deliverables.
• Coordinate with CQV teams during equipment and facility qualification activities.
• Monitor project progress and resource requirements, escalating issues where necessary.

Qualifications & Experience:

• 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, commissioningand 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 controlstrategiesand cleanroom classification standards (ISO 14644 and EU GMP).
• Experience supporting validation activities, including equipment qualification and cleaning validation.
• Working knowledge of HVAC systems, pressurecascadesand environmental monitoring requirements.
• Experience managing contractors and coordinating multidisciplinary project teams.
• Strong project planning, scheduling,budgetingand risk management skills.
• Excellent communication,organisationand stakeholder management skills.
• Proficient in Microsoft Office applications and project management software.
• Experience supporting regulatory inspections and audits would beadvantageous.