Construction Project Engineer

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

Job summary

CareerWise Recruitment is seeking a technically strong engineer for a Waterford-based pharmaceutical client for a 12-month contract. The role combines SME work in cleanroom construction and GMP processes with project management across design, construction, commissioning and qualification phases, including aseptic processing and FDA/EMA compliance considerations.

The candidate will guide design, qualification lifecycle activities (DQ/IQ/OQ/PQ), ensure EU GMP Annex 1 and 21 CFR Part 211 alignment,

Qualifications

• Technically strong engineer with hands-on GMP experience in cleanroom construction and GMP processes.
• Experience leading design, construction, commissioning and qualification phases.
• Familiarity with aseptic processing environments, lyophilization systems and regulatory inspections.

Responsibilities

• Manage all elements of assigned projects – schedule, cost, scope, safety, quality, and regulatory compliance.
• Lead design management and ensure GMP/GDP standards.
• Coordinate design meetings and ensure timely action closure with proper documentation.

Skills

GMP expertise

Project management

Cleanroom construction

HVAC systems

FDA/EMA compliance

CQV coordination

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.