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Senior CQ Utility Field Engineer

OVERVIEW

Location:

Lebanon, IN — 100%

On-Site Schedule:

Monday-Friday; 40+ hours/week; team on-site by 7AM; overtime and occasional weekend/holiday work as required

Duration:

12-month initial contract with anticipated extensions

Start:

ASAP — interviews will be scheduled quickly

Pay Rate:

W2 - $80-85/hr + 180/day Per Diem | 1099/C2C - $105-115/hr

ROLE SUMMARY

Planet Pharma is sourcing a Senior Commissioning & Qualification (C&Q) Utility Field Engineer for a large-scale pharmaceutical capital program at an active GMP manufacturing facility. This is a hands-on, field-execution role embedded within a project C&Q team delivering commissioning and qualification of clean and black utility systems. The position requires daily field presence, strong technical documentation skills, and deep familiarity with GMP utility systems in a regulated environment.

SYSTEMS IN SCOPE

Portable and non-portable water systems, Water for Injection (WFI) Dark and clean steam; CIP/SIP systems Compressed air and process gases (plant and instrument level) Cleanroom HVAC and building utility systems Water loop and utility loop systems; loop tuning Transfer stations

KEY RESPONSIBILITIES

Execute commissioning and qualification activities for clean and black utility systems including water, steam, HVAC, and process gases Develop, review, and execute C&Q protocols (IQ, OQ, PQ) and supporting documentation in alignment with project and regulatory requirements Perform P&ID walkdowns, loop checks, component verifications, and functional testing Support FAT/SAT activities, equipment installation verification, punch list tracking, and issue resolution Generate and maintain turnover packages (TOPs), traceability matrices, and qualification records Utilize Kneat (or equivalent eQMS) to manage, execute, and document qualification activities Collaborate cross-functionally with QA, validation, automation, engineering, and construction teams Document deviations, support root cause investigation, and drive timely closeout Ensure compliance with FDA, EMA, and applicable regulatory guidelines; apply c

GMP, ASTM

E2500, and risk-based C&Q principles

REQUIRED 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 experience with clean utility systems (WFI, clean steam, HVAC, compressed gases) Proficiency in Kneat or comparable eQMS/protocol execution platforms Solid working knowledge of P&IDs, engineering documentation, and GMP protocol standards Understanding of c

GMP, ASTM

E2500, and risk-based commissioning & qualification frameworks Strong technical writing, organizational, and communication skills

PREFERRED QUALIFICATIONS

Experience on greenfield or major facility expansion capital programs Exposure to DeltaV, SCADA, or building management/automation systems Familiarity with commissioning tracking tools or electronic turnover documentation systems FAT execution experience validating equipment functionality and performance Prior embedded C&Q or CQV department role within an owner/operator or EPCM environment