Project Engineer

Wallace Myers International; Waterford; On-site; EUR 83,000 - 96,000; Full time

Benefits offered by this job

€60-€70/hour

Job summary

Wallace Myers International is assisting a confidential, global biopharmaceutical leader in Waterford to recruit an experienced Project Engineer for a landmark SMART Factory site. You will lead GMP facility upgrades and cleanroom construction in a highly regulated environment, driving design, commissioning and qualification to completion.

As GMP and Cleanroom SME, you will manage contractors, coordinate lifecycle qualification (DQ/IQ/OQ/PQ), and ensure alignment with FDA/EMA requirements while

Qualifications

• Bachelor's degree in Engineering or equivalent.
• 5–10 years' experience delivering engineering projects in pharma/biotech GMP environments.
• Proven experience with cleanroom construction, commissioning and qualification.
• Strong GMP/GDP knowledge and regulatory compliance frameworks.
• Experience supporting FDA/EMA inspections is desirable.

Responsibilities

• Own project delivery across schedule, cost, scope, safety, quality, and regulatory compliance for GMP facility upgrade and cleanroom construction projects.
• Act as GMP & Cleanroom SME, ensuring all works comply with EU GMP Annex 1, FDA aseptic processing guidelines (21 CFR Part 211), and site quality standards.
• Lead and coordinate cleanroom qualification activities across the full lifecycle - Design, Installation, Operational, and Performance Qualification (DQ/IQ/OQ/PQ).
• Apply cleanroom classification requirements (ISO 14644, EU GMP Grades A-D), environmental monitoring strategies, and contamination control principles.
• Review and approve design documentation for cleanroom HVAC systems, pressure cascades, airlock configurations, and material/personnel flow layouts.
• Manage contractor performance, project governance, and stakeholder reporting throughout the project lifecycle.
• Partner closely with Quality Assurance, Validation, and Manufacturing teams to safeguard GMP compliance at every phase.
• Support inspection readiness and audit preparation activities for FDA and EMA.

Skills

GMP knowledge/gdp

Regulatory compliance

Project delivery

Cleanroom experience

Environmental monitoring

Education

Bachelor's degree in Engineering

Tools

HVAC systems

Environmental monitoring

Job description

Job Description

THE OPPORTUNITY

On behalf of a confidential, global biopharmaceutical leader, we are seeking an experienced Project Engineer to join a landmark SMART Factory site in Waterford, one of the most technologically advanced manufacturing campuses in Ireland, where AI-driven automation and next-generation cleanroom technology are transforming how medicines are made. This role sits within a highly regulated pharmaceutical manufacturing environment, supporting a portfolio of GMP facility upgrades and cleanroom construction projects. You will operate as both a technical subject matter expert in cleanroom and GMP processes, and a project leader driving design, construction, commissioning, and qualification through to completion.

WHAT YOU'LL BE DOING

• Own project delivery across schedule, cost, scope, safety, quality, and regulatory compliance for GMP facility upgrade and cleanroom construction projects.
• Act as GMP & Cleanroom SME, ensuring all works comply with EU GMP Annex 1, FDA aseptic processing guidelines (21 CFR Part 211), and site quality standards.
• Lead and coordinate cleanroom qualification activities across the full lifecycle - Design, Installation, Operational, and Performance Qualification (DQ/IQ/OQ/PQ).
• Apply cleanroom classification requirements (ISO 14644, EU GMP Grades A-D), environmental monitoring strategies, and contamination control principles.
• Review and approve design documentation for cleanroom HVAC systems, pressure cascades, airlock configurations, and material/personnel flow layouts.
• Manage contractor performance, project governance, and stakeholder reporting throughout the project lifecycle.
• Partner closely with Quality Assurance, Validation, and Manufacturing teams to safeguard GMP compliance at every phase.
• Support inspection readiness and audit preparation activities for FDA and EMA.

WHAT YOU'LL BRING

• 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.
• Working knowledge of HVAC systems, pressure cascades, and environmental monitoring requirements.
• Experience supporting FDA or EMA inspections is desirable.

WHAT'S ON OFFER

• Initial 12-month contract at €60-€70 per hour, with strong scope to extend on a long-term capital programme.
• A genuinely SMART, AI-enabled manufacturing environment, hands-on exposure to next-generation pharma technology.
• High-profile capital project exposure on a market-leading global biopharma campus.
• A confidential engagement - full details shared directly with shortlisted candidates.