Cleaning Validation Specialist

Cleaning Validation Specialist I – Onsite | Contract Role

Position Summary

We are seeking a Cleaning Validation Specialist I to support and coordinate cleaning validation activities within a regulated pharmaceutical manufacturing environment. This role is responsible for the development, execution, and documentation of cleaning validation studies, ensuring compliance with regulatory standards and internal procedures.

The selected candidate will provide hands-on support for validation execution, data analysis, troubleshooting, and cross-functional collaboration to ensure effective and compliant cleaning processes.

Key Responsibilities

Cleaning Validation Execution & Support

• Coordinate and execute cleaning validation activities, including protocol development, execution, and reporting.
• Support authoring and execution of validation protocols (CV/CHT/SHT), including study completion and documentation closure.
• Perform on-floor execution of cleaning validation activities, including sampling and technical support.
• Manage validation samples throughout the lifecycle, including collection, tracking, and documentation.
  
  

Process & Technical Support

• Design and develop cleaning procedures for new products and manufacturing equipment.
• Provide technical support for cleaning processes associated with manufacturing operations.
• Utilize process data (e.g., PI systems) to support trend analysis and validation activities.
• Support equipment such as autoclaves, parts washers, and CIP systems within the cleaning validation program.
  
  

Investigations & Compliance

• Investigate deviations, discrepancies, and out-of-specification (OOS) results related to cleaning activities.
• Perform root cause analysis and implement corrective actions as needed.
• Ensure timely resolution and closure of validation-related deviations and incidents.
• Support periodic review of cleaning validation studies.
  
  

Collaboration & Training

• Collaborate with cross-functional teams, including Quality, Manufacturing, and Engineering, to align validation activities with project goals.
• Provide training to Manufacturing and QA/QC personnel on cleaning validation procedures and documentation.
  
  

Qualifications

• Bachelor’s degree in Science, Engineering, or a related field
• OR
• 8 years of relevant experience in the pharmaceutical industry with hands-on cleaning validation experience
• Minimum of 5 years of experience in cleaning validation within pharmaceutical or biotechnology environments
  
  

Required Skills & Competencies

• Strong knowledge of cleaning validation principles and lifecycle management
• Hands-on experience with KNEAT validation systems
• Experience with validation sample management
• Strong understanding of cGMP, FDA, and OSHA regulations
• Ability to interpret equipment design, P&IDs, and process flow diagrams
• Proficiency in data analysis and trending tools (e.g., PI systems)
• Strong technical writing and documentation skills
• Excellent analytical, troubleshooting, and problem-solving abilities
• Strong project management and organizational skills
• Effective communication and cross-functional collaboration skills
• Ability to work independently and manage multiple priorities
  
  

Work Environment

• Contract Type: Professional services
• Duration: Approximately 12 months
• Location: Fully onsite
• Schedule: Full-time, administrative shift
• Flexibility: Availability to support non-standard hours based on project needs
  
  

Why This Role

This position offers the opportunity to contribute to critical validation activities in a highly regulated environment, supporting compliance, process reliability, and operational excellence.