Cleanroom Project Engineer

Wallace Myers International; Munster; On-site; EUR 70,000 - 100,000; Full time

Job summary

Wallace Myers International is seeking a Project Engineer specializing in GMP and cleanroom construction to support upgrades at a Waterford site within a regulated pharmaceutical environment.

The role covers design, construction, commissioning, and qualification across DQ/IQ/OQ/PQ, with strong emphasis on regulatory compliance and documentation control. A 12-month contract is specified.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Process, or related).
• 5–10 years' experience delivering engineering projects in pharma/biotech GMP environments.
• Proven experience with cleanroom construction, commissioning and qualification.
• Strong GMP/GDP knowledge; regulatory compliance familiarity; inspections desirable.
• Trade certification with GMP site management experience considered.

Responsibilities

• Manage all elements of assigned projects: schedule, cost, scope, safety, quality and regulatory compliance.
• Lead design management and ensure GMP/GDP compliance and user requirements alignment.
• Attend and document project and design meetings; close actions on time.
• Maintain governance and milestone reporting; manage contractor performance.
• Support tendering and coordinate with Document Control for GEDMS submissions.
• Act as SME for GMP and cleanroom; oversee qualification activities across lifecycle.

Skills

GMP environments

Project management

Design management

Regulatory compliance

Stakeholder management

Education

Bachelor's degree in Engineering

Tools

MS Office

Project management software

Job description

Project Engineer - Cleanroom Construction (GMP) to work at my clients Biopharma and device site in Waterford.

Ltd contract -12 months.

Job Title

Project Engineering - Project Engineer (GMP & Cleanroom Construction)

About the Opportunity

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.

Project Engineering provides project delivery services across the Waterford campus to support manufacturing operations, site infrastructure, and technology improvements within a controlled and regulated environment.

Key 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 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.

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.

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.