Commissioning and Qualification Engineer – Pharmaceutical Utilities

Key Responsibilities

Commission and qualify pharmaceutical utility systems , including :

Clean Utilities :

Water for Injection (WFI) systems

Clean Steam generation and condensate return systems

RO / DI Water and Pure Steam systems

Clean Compressed Air and Nitrogen systems

Black Utilities :

Chillers and chilled water systems

Boilers, heating hot water, and plant steam systems

HVAC systems including AHUs, ductwork, HEPA filtration, and BMS integration

Process gases (CO , O , N , etc.) and related piping / control systems

Electrical distribution and emergency power systems

Develop and execute commissioning protocols, IQ / OQ / PQ documentation, and test scripts for utility systems.

Perform field inspections and system walkdowns , verifying installation against design drawings and specifications.

Collaborate with cross-functional teams to ensure seamless GMP integration of utilities into manufacturing operations.

Support risk assessments, change control, and impact analyses related to utility systems.

Troubleshoot and resolve issues during commissioning and qualification to ensure timely completion and documentation.

Maintain compliance with FDA, EMA, ISPE, and ICH Q9 / Q10 regulatory standards.

Act as a Subject Matter Expert (SME) during audits and inspections.

Required Qualifications

Bachelor's degree in Mechanical, Chemical, or Electrical Engineering (or related discipline).

Minimum 3 years of experience in commissioning and qualification of utility systems in a pharmaceutical or biotech setting.

Strong understanding of clean and black utilities and their role in GMP operations .

Experience in validation lifecycle documentation and regulatory compliance.

Proficiency in technical writing and protocol development .

Excellent communication, organization, and problem-solving skills .