Utilities Engineer

Clean Utilities Lead

We are seeking a Clean Utilities Lead to spearhead the design, commissioning, and long‑term support of critical clean utility systems for a major biopharmaceutical manufacturing start‑up. In this critical leadership role, you will own the clean utilities workstream, ensure system compliance with strict global standards, and coordinate cross‑functionally to guarantee a seamless startup and robust daily operations.

• Workstream Ownership: Act as the lead technical authority and owner for all clean utility systems, actively supporting equipment qualification and ensuring high system reliability.
• System Design & Engineering: Direct the engineering, design, and integration of essential systems, including:
• PW (Purified Water) &
  WFI (Water for Injection) generation, storage, and distribution.
• Pure Steam / Clean Steam systems.
• Generation technologies including distillation, membrane filtration, and vapor compression.
• Troubleshooting & Optimization: Analyze system P&IDs, determine appropriate materials of construction, and resolve complex clean utility issues such as biofilm formation, rouging, and distribution loop inefficiencies.
• Quality & Pharmacopeia Compliance: Ensure all systems align with USP/EP pharmacopeia requirements, implementing strict microbial control, pyrogen/endotoxin testing protocols, and complete system validation (IQ/OQ/PQ).
• Startup Leadership: Manage the clean utilities timeline to support a safe, compliant, and on‑schedule manufacturing facility start‑up.

• Experience: 8+ years of dedicated experience designing, commissioning, and supporting clean utilities within a regulated biopharmaceutical or biotechnology environment.
• Technical Expertise: Comprehensive, hands‑on knowledge of WFI/PW distribution loops, sanitization regimens, storage dynamics, and point‑of‑use engineering.
• Education: Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related technical discipline.
• Compliance Knowledge: Thorough understanding of global GMP, USP/EP standards, sanitization methodologies, and validation protocols.
• Leadership
  
  Skills:
  
  Proven ability to manage a critical project workstream, drive technical decision‑making, and collaborate with validation and operations leads.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short‑term disability insurance, additional voluntary benefits, commuter benefits and 401(K) plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.