Mechanical Critical Utilities SME

Job Title: Mechanical Critical Utilities SME

Location: Maryland Onsite

Duration: 12+ months with long-term potential

Employment Type: W2 only

Role Overview

We are seeking an experienced Mechanical Critical Utilities SME to provide technical leadership for GMP-critical utility systems supporting a major pharmaceutical capital project. This role will work across design, engineering, commissioning, qualification, and operations.

Key Responsibilities

• Provide technical guidance for WFI, purified water, clean steam, compressed air, nitrogen, and related utility systems.
• Support basic and detailed engineering design activities.
• Review P&IDs, specifications, drawings, calculations, and vendor documentation.
• Develop and review URS and provide technical input on system requirements.
• Participate in vendor evaluations, FAT/SAT, DQ, IQ/OQ, and C&Q activities.
• Support commissioning, startup, qualification, and operational readiness.
• Work closely with engineering contractors, project teams, CQV, and site operations.
• Ensure utility systems meet GMP, GEP, reliability, maintainability, and operational requirements.

Qualifications

• 10+ years of mechanical or utilities engineering experience in pharmaceutical or biotechnology facility experience.
• Hands-on knowledge of GMP-critical and clean utility systems.
• Strong WFI and pharmaceutical water-system experience.
• Experience with pharmaceutical capital projects and engineering design reviews.
• Ability to interpret P&IDs, engineering drawings, calculations, and vendor packages.
• Experience supporting commissioning, startup, FAT/SAT, and qualification.
• Knowledge of GMP and GEP requirements.
• Plant/operations experience preferred.
• Ozone-based pharmaceutical water-system experience is a major plus.