Clean Utilities SME Engineer (Biopharma)

Location: Waterford, Ireland; full-time, fixed-term contract for 23 months

Salary: €54,800–€73,067 per year

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.

What you will do

• Lead technical design reviews and develop user requirements and technical specifications for purified water, water for injection, clean steam, and cleanroom HVAC systems.
• Act as the technical escalation point for complex utility failures and lead root cause investigations and CAPA development.
• Support regulatory inspections, audits, qualification documentation, and periodic requalification activities.
• Drive reliability, maintainability, energy-efficiency, and continuous-improvement initiatives across clean utilities infrastructure.
• Evaluate emerging technologies and digitalize monitoring, alarming, and data trending for critical systems.
• Mentor maintenance technicians and junior engineers while collaborating with Quality, Validation, Production, EHS, Reliability Engineering, vendors, and service providers.

Requirements

• Bachelor’s degree in Mechanical, Chemical, or related Engineering, or an equivalent technical qualification.
• 7+ years of experience operating and troubleshooting GMP critical utility systems in pharmaceutical, biotech, or comparable high-purity manufacturing.
• Experience leading root cause investigations, CAPA development, and technical support during regulatory audits or inspections.
• Working knowledge of CMMS, IQ/OQ/PQ qualification protocols, and change control processes.
• Technical expertise in GMP compliance, energy engineering, utility systems design, project management, and preventive and corrective maintenance.

Nice to have

• Familiarity with emerging digital and process analytical technologies.
• Experience in semiconductor, food and beverage, or another comparable high-purity manufacturing environment.

Culture & Benefits

• Supportive, future-focused environment centered on scientific progress and improving patient outcomes.
• Opportunities for professional growth through promotion or lateral career moves, locally and internationally.
• Rewards package recognizing contribution and impact.
• Healthcare, prevention, and wellness benefits.
• At least 14 weeks of gender-neutral parental leave.