Project Engineer (GMP & Cleanroom Construction) required for Life Sciences client based in Waterford. Initial 12 month contract.

The Project Engineer will support the execution of a portfolio of GMP facility upgrades and cleanroom construction project within a highly regulated pharmaceutical manufacturing environment. The successful candidate will be responsible for the delivery of all project elements including schedule, cost, scope, safety, quality, and regulatory compliance.

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.

Responsibilities:

General

- 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.
- Support tendering processes and coordinate with Document Control for timely submission to GEDMS.

GMP & Cleanroom SME Responsibilities

- 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.
- Collaborate with Quality Assurance, Validation, and Manufacturing teams to ensure GMP compliance throughout all project phases.
- Support preparation and execution of commissioning and qualification protocols.
- Ensure proper documentation per GMP requirements, including batch records, deviations, and CAPAs.

Schedule Management

- Develop, maintain, and track project schedules.
- Identify, record, and communicate delays via the PCC process.
- Lead schedule workshops and proactively challenge contractors to maintain milestones.

Scope & Cost Management

- Develop and maintain project URS/URB documentation.
- Control scope and cost changes, ensuring all variations are captured through formal change processes.
- Align budget and schedule with scope requirements and prevent scope creep.

Safety

- 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.

Quality & Regulatory Compliance

- Ensure full compliance with site GMP, GDP, and Change Control processes.
- Ensure all cleanroom construction activities maintain required environmental classifications throughout the works programme.
- Support risk assessments for GMP impact areas including cleaning validation, environmental monitoring, and sterility assurance.
- Coordinate with Quality Assurance for deviation management and CAPA implementation.
- Ensure proper documentation control for all validation deliverables, protocols, and reports in line with regulatory expectations.
- Support regulatory inspection readiness and audit preparation activities for FDA and EMA.
- Maintain documentation control systems for submittals, RFIs, specifications, and qualification records.
- Ensure documentation reviews are completed by all stakeholders and filed per A21/Deliverables List.
- Engage with key departments to ensure successful and compliant project outcomes.

Validation & Qualification Coordination

- Coordinate with the CQV team for equipment and facility qualification activiti

Resources

- Monitor progress against the plan and escale resource constraints as needed.

Requirements:

- Bachelor's degree in Engineering (Mechanical, Chemical, Process, or related discipline) or equivalent qualification.
- 5–10 years' experience in engineering project delivery within pharmaceutical or biotech GMP environments.
- Proven experience with cleanroom construction, commissioning, and qualification.
- Robust 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.

📌 Project Engineer (Kingston)
🏢 CareerWise Recruitment
📍 Kingston