Sr. C&Q Utility Field Engineer

Planet Pharma; Lebanon (IN); Presencial; USD 110.000 - 158.000; Jornada completa

Descripción de la vacante

Planet Pharma is seeking a Senior Commissioning & Qualification Utility Field Engineer for a large-scale GMP capital project in Lebanon, IN. This on-site role requires daily field presence, hands-on C&Q work on water, steam, HVAC, and process gases, and meticulous documentation within a project team.

Responsibilities include developing IQ/OQ/PQ protocols, performing walkdowns and tests, managing turnover packages, and maintaining compliance with FDA/EMA guidelines using Kneat or similar eQMS

Formación

• 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 cGMP, ASTM E2500, and risk-based commissioning & qualification frameworks.
• Strong technical writing, organization, and communication skills.

Responsabilidades

• 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 cGMP, ASTM E2500, and risk-based C&Q principles.

Descripción del empleo

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 cGMP, 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 cGMP, ASTM E2500, and risk-based commissioning & qualification frameworks
• Strong technical writing, organization, 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