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.

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