Senior C&Q Utility Field Engineer - GMP Pharma (On-Site)

Planet Pharma; Lebanon (IN); Presencial; USD 110 000 - 158 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Descrição da oferta de emprego

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