Senior CQ Utility Field Engineer

United Pharma; Indiana; On-site; USD 110,000 - 165,000; Full time

Job summary

United Pharma is seeking an experienced Senior Commissioning & Qualification (C&Q) Utility Field Engineer to support a large-scale pharmaceutical capital project at an active GMP manufacturing facility. The role involves hands-on commissioning, qualification, field execution, and documentation for clean and black utility systems.

You will develop IQ/OQ/PQ protocols, perform P&ID walkdowns, support FAT/SAT, prepare turnover packages, and collaborate with QA, Validation, Automation,

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 5+ years of C&Q experience in GMP pharmaceutical or biotech facilities.
• Hands-on clean utilities experience, including WFI, clean steam, HVAC, and compressed gases.
• Proficiency in Kneat or comparable electronic qualification platforms.
• Strong knowledge of P&IDs, GMP protocols, and technical writing.

Responsibilities

• Execute C&Q activities for WFI, water systems, clean and dark steam, CIP/SIP, HVAC, and gases.
• Develop and execute IQ/OQ/PQ protocols and qualification documentation.
• Perform P&ID walkdowns, loop checks, component verification, loop tuning, and functional testing.
• Support FAT/SAT, equipment installation verification, punch list management, and issue resolution.
• Prepare turnover packages (TOPs), traceability matrices, and qualification records using Kneat or equivalent eQMS platforms.
• Collaborate with QA, Validation, Automation, Engineering, and Construction teams.
• Document deviations, support root cause investigations, and ensure timely closure.
• Apply cGMP, FDA/EMA requirements, ASTM E2500, and risk-based C&Q principles.

Skills

C&Q experience

P&IDs knowledge

Technical writing

GMP/compliance knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, or a related technical field

Tools

Kneat

eQMS platforms

DeltaV

SCADA

Automation systems

Job description

We are seeking an experienced Senior Commissioning & Qualification (C&Q) Utility Field Engineer to support a large-scale pharmaceutical capital project at an active GMP manufacturing facility. The role involves hands-on commissioning, qualification, field execution, and documentation for clean and black utility systems.

Key Responsibilities & Requirements:

• Execute C&Q activities for WFI, portable/non-portable water systems, clean and dark steam, CIP/SIP, compressed air, process gases, cleanroom HVAC, and building utilities.
• Develop, review, and execute IQ/OQ/PQ protocols and qualification documentation.
• Perform P&ID walkdowns, loop checks, component verification, loop tuning, and functional testing.
• Support FAT/SAT, equipment installation verification, punch list management, and issue resolution.
• Prepare turnover packages (TOPs), traceability matrices, and qualification records using Kneat or equivalent eQMS platforms.
• Collaborate with QA, Validation, Automation, Engineering, and Construction teams.
• Document deviations, support root cause investigations, and ensure timely closure.
• Apply cGMP, FDA/EMA requirements, ASTM E2500, and risk-based C&Q principles.

Must-Have Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 5+ years of C&Q experience in pharmaceutical or biotech GMP facilities.
• Hands-on clean utilities experience, including WFI, clean steam, HVAC, and compressed gases.
• Proficiency in Kneat or comparable electronic qualification platforms.
• Strong knowledge of P&IDs, engineering documentation, GMP protocols, and technical writing.

Preferred Qualifications:

• Greenfield projects or major facility expansion experience.
• Exposure to DeltaV, SCADA, or building management/automation systems.
• Experience with FAT execution, commissioning tracking tools, and electronic turnover documentation.
• Previous embedded C&Q/CQV experience in an owner/operator or EPCM environment.