Project Engineer (GMP & Cleanroom)

Role Summary:

• Our client based in Co. Waterford is looking for a Project Engineer (GMP & Cleanroom Construction) to join their busy bio-pharmaceutical facility.
• 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 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
• We are looking for an experienced individual to hit the ground running who has delivered on significant projects within a high regulated environment.
• Ideally will also have education / work experience & aspirations to develop clear skills and competences around dealing with a live pharmaceutical production environment. The capital projects team are best in class in the execution of projects safely.

Core Duties and 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.
• Support tendering processes and coordinate with Document Control for timely submission to GEDMS.

GMP & Cleanroom 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 activity.

Resources

• Monitor progress against the plan and escalate resource constraints as needed.

Minimum Qualifications and Experience:

• 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.
• 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.
• Strong background in project planning, scheduling, budgeting, and risk management.
• Ability to manage complex multi-stakeholder projects to successful completion within a regulated environment.
• Demonstrated experience with cleanroom construction, qualification, and GMP facility upgrades.
• Strong understanding of aseptic processing, contamination control strategies, and cleanroom design principles.
• Familiarity with cleanroom classification standards (ISO 14644, EU GMP Grades A–D).
• Understanding of the qualification and validation lifecycle including Computer System Validation (CSV), equipment qualification, and cleaning validation.
• Working knowledge of HVAC systems, pressure cascades, and environmental monitoring requirements.
• Working knowledge of PSCS role and responsibilities.
• Proficiency in MS Office tools (Excel, PowerPoint, Word) and project management software.
• Proven ability to lead cross-functional teams and coordinate contractors in a GMP setting.
• Strong written and verbal communication skills.
• Analytical problem-solving and decision-making capability