6244 - CIP (Clean-in-Place) Engineer

We are seeking a Clean-in-Place (CIP) Engineer with hands-on experience overseeing the commissioning and qualification of Clean-In-Place (CIP) systems. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.

Clean-in-Place (CIP) Engineer Responsibilities:

CIP System Leadership

• Serve as the commissioning and qualification (C&Q) lead for CIP systems (responsibilities described below).
• Develop and optimize CIP cleaning cycles to meet operational and quality standards.
• Supervise the safe introduction and handling of caustic solutions during cleaning cycle development.

C&Q Lead Responsibilities

Commissioning and Qualification Documentation

• Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications.
• Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
• Engage with design engineers and SMEs to clarify system intent and operational requirements.
• Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation.
• Create Commissioning Test Plans that translate design intent into testable steps.
• Coordinate with the Automation Team to incorporate all automation functional testing.
• Collaborate with SMEs to ensure system requirements are accurately reflected in test plans.
• Develop Installation, Operational, and Qualification (IOQ) protocols.
• Prepare and submit summary reports documenting commissioning and qualification activities.

System Ownership and Execution

• Take custody of the system post-construction and maintain ownership through C&Q completion.
• Perform Lockout/Tagout (LOTO) for system safety.
• Conduct pre-startup safety checks and risk assessments.
• Prepare daily pre-task plans and verify team readiness for safe execution.
• Attend daily commissioning meetings to coordinate activities.
• Execute commissioning and IOQ protocols.
• Resolve issues arising during execution.
• Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required.

Requirements:

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related technical discipline
• 10+ years of role-specific experience
• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments
• Hands-on experience with CIP systems and automated cleaning processes
• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)
• Ability to work independently while coordinating with cross-functional project teams
• Strong technical documentation and communication skills
• Experience using digital validation platforms such as Kneat
• Experience supporting FAT/SAT, commissioning, and equipment startup
• Familiarity with automated process systems and PLC-based equipment
• Experience in biologics or large-scale biopharmaceutical manufacturing environments
• Onsite job requirement in Apex, NC