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 escalate resource constraints as needed.
Essential Skill Set
Project Management Skills
- Strong background in project planning, scheduling, budgeting, and risk management.
- Ability to manage complex multi-stakeholder projects to successful completion within a regulated environment.
Technical Skills
- 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.
Leadership and Communication
- 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 capabilitie
Essential 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.
- 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 contact James Farrar today for further information email: jfarrar@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.