GMP Utilities Validation Engineer

Job Title: GMP Utilities Validation Engineer Location: Lebanon, IN Experience: 3+ Years

Duration: 12+ Months Contract

Job Description

We are seeking experienced GMP Utilities Validation Engineer to join our team and support commissioning and qualification of pharmaceutical utility systems in a GMP-regulated environment.

Key Responsibilities:

Commission and qualify pharmaceutical utility systems, including:

Clean Utilities: WFI generation and distribution, clean steam, pure steam, RO/DI water systems, compressed air, and nitrogen systems for cleanrooms.

Black Utilities: Chillers, chilled water, boilers, heating hot water, plant steam systems, HVAC (AHUs, ductwork, HEPA filtration, BMS integration), process gases (CO₂, O₂, N₂), and electrical distribution/emergency power.

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

Conduct field inspections, system walkdowns, and verification against design drawings and specifications.

Collaborate with Engineering, Validation, QA, and Operations teams to ensure seamless integration of utilities into GMP operations.

Support risk assessments, impact analyses, and change control processes for utility systems.

Troubleshoot and resolve issues during commissioning and qualification phases, ensuring timely documentation.

Maintain compliance with FDA, EMA, ICH Q9/Q10, and ISPE Baseline Guides.

Serve as a Subject Matter Expert (SME) during internal and external audits and inspections.

Required Qualifications:

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

Minimum 3 years of experience in commissioning and qualification of utility systems in pharmaceutical or biotech environments

Strong understanding of clean and black utility systems and their role in GMP manufacturing

Experience with validation lifecycle documentation and regulatory compliance

Proficiency in technical writing and protocol development

Excellent communication, organizational, and problem-solving skills

Preferred Qualifications

• Experience with automation systems (BMS, SCADA, PLCs) and computerized system validation (CSV)

• Familiarity with ISPE C&Q methodologies, ASTM E2500, and risk-based validation approaches

• Project management experience or certification (PMP)

• Knowledge of environmental monitoring systems and cleanroom classifications

• Work Environment:

• On-site role in a GMP-regulated pharmaceutical facility

• May require off-hours or weekend work during critical commissioning phases

• Physical activity includes walking, climbing ladders, and inspecting mechanical systems in utility areas