GMP Facility Upgrade Project Engineer (Cleanroom)

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

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.