Project Construction Engineer

A Construction Project Engineer is required by CareerWise 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.

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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