G3 Tech Consultants is hiring: Cleaning Validation in Holly Springs

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Strategic and Business Development | G3 Tech

We are seeking a detail-oriented and proactive Cleaning Validation Engineer with strong expertise in cleaning validation lifecycle management within a GMP-regulated manufacturing environment. The ideal candidate will lead the creation and execution of validation documentation, perform critical risk assessments, and drive continuous improvement initiatives. This role requires cross-functional collaboration and the ability to manage validation activities with minimal impact on production. A strong emphasis is placed on ownership, documentation accuracy, and a positive, solutions-driven approach.

We are seeking a detail-oriented and proactive Cleaning Validation Engineer with strong expertise in cleaning validation lifecycle management within a GMP-regulated manufacturing environment. The ideal candidate will lead the creation and execution of validation documentation, perform critical risk assessments, and drive continuous improvement initiatives. This role requires cross-functional collaboration and the ability to manage validation activities with minimal impact on production. A strong emphasis is placed on ownership, documentation accuracy, and a positive, solutions-driven approach.

• Lead the development of cleaning validation documentation including master plans, protocols, and reports.
• Author and execute cleaning validation protocols (IQ/OQ/PQ) for equipment, CIP/SIP systems, and utilities.
• Conduct risk assessments and gap analyses based on historical data to ensure regulatory compliance (FDA, EMA, WHO).
• Implement cleaning validation strategies including hold time studies, swab/rinse sampling, recovery studies, and worst-case product matrix identification.
• Perform MACO calculations using PDE, therapeutic dose, and toxicological data.
• Manage the cleaning validation lifecycle, including revalidation criteria and continuous improvement initiatives.
• Collaborate closely with QA, QC, Engineering, and Manufacturing teams to minimize production disruptions.
• Review and approve related SOPs, batch records, protocols, and reports.
• Investigate deviations or failures, and write associated CAPAs.
• Liaise effectively with internal stakeholders and assist in project planning and execution.

• Bachelor’s degree in a relevant field (e.g., Engineering, Life Sciences).
• 3 to 5 years of experience in cleaning validation within a pharmaceutical or GMP-regulated environment.
• Proficient with ASTM E2500 or verification-based validation approaches.
• Experience with cross-functional collaboration and validation support in large-scale or GMP operational projects.
• Strong communication and organizational skills.
• Proactive, detail-oriented, with a can-do attitude and strong ownership.
• Capable of working independently and escalating issues when needed.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Management and Manufacturing

• Industries

  Business Consulting and Services

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