Construction Project Engineer

CareerWise Recruitment; Waterford; On-site; EUR 75,000 - 110,000; Full time

Job summary

CareerWise Recruitment is recruiting for a Waterford-based pharmaceutical client seeking a technically strong engineer with GMP and cleanroom expertise to lead design, construction, commissioning, and qualification projects. You will act as SME for GMP/cleanroom matters and manage cross-functional teams in a tightly regulated environment.

The role requires 5-7 years in engineering project delivery within pharma or biotech GMP environments; experience with FDA/EMA guidelines is desirable.

Qualifications

• Bachelor's degree in Engineering required; 5-7 years in engineering project delivery within pharmaceutical or biotech GMP environments.
• Proven experience with cleanroom construction, commissioning, and qualification.
• Strong understanding of GMP/GDP requirements and regulatory compliance frameworks.

Responsibilities

• Manage and be responsible for all elements of assigned projects – Schedule, Cost, Scope, Safety, Quality, and Regulatory Compliance.
• Lead design management and ensure compliance with scope, user requirements, and GMP/GDP standards.
• Attend project and design meetings, ensuring accurate documentation and timely action closure.
• Maintain project governance and report documentation including milestones.
• Manage contractor performance to ensure compliance with quality, schedule, safety, and GMP expectations.
• Act as the GMP and Cleanroom Subject Matter Expert (SME) for assigned projects and provide support to other project engineers as required.
• Ensure all works comply with EU GMP Annex 1, FDA aseptic processing guidelines (21 CFR Part 211), and site quality standards.
• Support and coordinate cleanroom qualification activities across the full lifecycle: DQ, IQ, OQ, PQ.
• Understand and apply cleanroom classification requirements (ISO 14644, EU GMP Grades A-D / ISO 5-8)
• Review and approve design documents for cleanroom HVAC systems, pressure cascades, airlock configurations, and material/personnel flow layouts.
• Ensure all works are planned and executed safely under the Safe Systems of Work.
• Ensure RAMS are prepared and implemented before works commence.
• Support the Construction Manager in ensuring safe project execution within GMP-controlled environments
• Coordinate with the CQV team for equipment and facility qualification activities
• Working knowledge of HVAC systems, pressure cascades, and environmental monitoring requirements.

Skills

GMP knowledge

Cleanroom experience

Project management

Regulatory compliance

Education

Bachelor's degree in Engineering

Job description

Recruitment for a 12 month contract position with our Waterford based pharmaceutical client. This role requires a technically strong engineer with hands-on experience in GMP environments who can operate both as a subject matter expert (SME) in cleanroom construction and GMP processes, and as a project manager capable of leading design, construction, commissioning, and qualification phases. Experience with aseptic processing environments, lyophilization systems, and FDA compliance projects is highly desirable !!!

THE ROLE

• Manage and be responsible for all elements of assigned projects – Schedule, Cost, Scope, Safety, Quality, and Regulatory Compliance.
• Lead design management and ensure compliance with scope, user requirements, and GMP/GDP standards.
• Attend project and design meetings, ensuring accurate documentation and timely action closure.
• Maintain project governance and report documentation including milestones.
• Manage contractor performance to ensure compliance with quality, schedule, safety, and GMP expectations.
• Act as the GMP and Cleanroom Subject Matter Expert (SME) for assigned projects and provide support to other project engineers as required.
• Ensure all works comply with EU GMP Annex 1, FDA aseptic processing guidelines (21 CFR Part 211), and site quality standards.
• Support and coordinate cleanroom qualification activities across the full lifecycle: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Understand and apply cleanroom classification requirements (ISO 14644, EU GMP Grades A-D / ISO 5-8), environmental monitoring strategies, and contamination control principles.
• Review and approve design documents for cleanroom HVAC systems, pressure cascades, airlock configurations, and material/personnel flow layouts.
• Ensure all works are planned and executed safely under the Safe Systems of Work.
• Ensure RAMS are prepared and implemented before works commence.
• Support the Construction Manager in ensuring safe project execution within GMP-controlled environments
• Coordinate with the CQV team for equipment and facility qualification activities
• Working knowledge of HVAC systems, pressure cascades, and environmental monitoring requirements.

REQUIREMENTS

• Bachelor's degree in Engineering (Mechanical, Chemical, Process, or related discipline) or equivalent qualification. 5-7 years' experience in engineering project delivery within pharmaceutical or biotech GMP environments.
• Proven experience with cleanroom construction, commissioning, and qualification.
• Strong understanding of GMP/GDP requirements and regulatory compliance frameworks.
• Experience supporting FDA or EMA inspections is desirable.
• Trade certification with substantial GMP site management experience will be considered.

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