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C+Q Utilities Engineer - Pharmaceutical Manufacturing

Job Type
Location
Center, Indiana
Salary
US$60 - US$110 per hour + *based on experience
Job Ref
BBBH2316761_1758829927
Date Added
September 25th, 2025
Consultant
rebecca schopfer

SRG, the leader in the Life Sciences human capital industry, is looking for a Commissioning and Qualification Utilities Engineer to join our clients pharmaceutical manufacturing team in Lebanon, Indiana. This person will be responsible for all Commissioning and Qualification of clean and black utility systems, gasses, chillers, WFI, clean steam in a pharmaceutical environment.

*Fully onsite position

*Rate will be discussed based on years of experience

*Long term contract

Must Haves:

  • Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related discipline).
  • Minimum 5 years of experience in commissioning and qualification of utility systems in a pharmaceutical or biotech environment. Higher level candidates will be considered.
  • 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 (e.g., 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 (e.g., PMP).
  • Knowledge of environmental monitoring systems and cleanroom classifications.

Responsibilities:

  • Commission and qualify pharmaceutical utility systems, including:

Clean Utilities:

  • WFI (Water for Injection) generation and distribution systems
  • Clean Steam generation and condensate return systems
  • Pure Steam and RO/DI Water systems
  • Compressed Air and Nitrogen systems for cleanroom use

Black Utilities:

  • Chillers and chilled water distribution systems
  • Boilers and heating hot water systems
  • Plant Steam systems
  • HVAC systems including AHUs, ductwork, HEPA filtration, and BMS integration
  • Process gases (CO₂, O₂, N₂, etc.) and associated piping and 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, system walkdowns, and verification of installation against design drawings and specifications.
  • Collaborate with Engineering, Validation, QA, and Operations 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 resolution and documentation.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

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