We are seeking an experienced Clean Utilities Engineer to provide client-side technical expertise for a large-scale Fill/Finish facility project in Dublin. You will be responsible for the design, commissioning, and qualification of critical systems, including WFI, Clean Steam, Pretreatment, and Process Air. This role spans the primary production building as well as site-wide infrastructure, including cold storage and laboratory reconfigurations.
Responsibilities
- Design Ownership: Lead client-side design reviews, including model reviews and technical assessments for instrumentation and procurement.
- Technical Oversight: Manage and review essential documentation (URS, HDS, SDS, P&IDs, and Equipment Specifications) to ensure alignment with site standards and Technical Authorities.
- Execution & Validation: Support Automation, C&Q, and Validation teams during loop checking, troubleshooting, and equipment package integration.
- Vendor & Site Management: Oversee Vendor Package Equipment, lead Factory/Site Acceptance Testing (FAT/SAT), and provide on-site supervision during the construction phase.
- Operations Integration: Coordinate with Metrology for calibration programs and assist Maintenance teams with MAXIMO data requirements.
- Project Controls: Track discipline-specific milestones and provide technical input on scheduling and cost management.
Candidate Requirements
Experience & Education
- Degree: Bachelor's degree in Chemical or Mechanical Engineering (or equivalent).
- Professional Background: 5+ years of experience in pharmaceutical design, construction, and start-up.
- Subject Matter Expertise: Proven track record with high-purity utility systems in large-scale biopharma environments.
Key Competencies
- Strong ability to challenge and defend technical design decisions.
- Willingness to travel for vendor FATs as required.
- Excellent collaboration skills for interfacing with Site SMEs, Engineering Technical Authorities, and cross-functional project teams.
