Position Summary
The Technical Lead will be responsible for providing technical direction and oversight for Cleaning Characterization, Cleaning Verification, CIP/SIP, equipment cleaning, and sterilization qualification activities. This role will coordinate document preparation and field execution and will ensure that activities are performed in accordance with approved procedures, protocols, acceptance criteria, and project requirements.
Key Responsibilities
• Develop the technical strategy for Cleaning Characterization and Sterilization Qualification activities.
• Develop and review Cleaning Characterization Protocols, Sterilization PQ Protocols, and their corresponding final reports.
• Evaluate equipment operation and process sequences as they relate to cleaning and sterilization activities.
• Review CIP and SIP circuits and associated operating parameters.
• Identify product contact surfaces and perform surface area calculations as required.
• Identify critical and non-critical process parameters and evaluate washer and autoclave load configurations.
• Coordinate and participate in field verification activities.
• Review cleaning and sterilization cycle results to confirm compliance with established protocol acceptance criteria.
• Support equipment Release for Use (RFU) and sterilization conditional release activities.
• Provide technical support during the evaluation of discrepancies, deviations, or nonconforming results.
• Recommend corrective actions and recovery plans when required.
• Participate in AM/PM project meetings during the execution phase.
• Coordinate the assignment of technical activities among validation personnel and follow up on completion.
Minimum Recommended Qualifications
• Bachelor's degree in engineering, Microbiology, Chemistry, Biotechnology, or a related technical field.
• At least 8 years of validation experience within the pharmaceutical or biotechnology industry.
• At least 5 years of hands-on experience in Cleaning Validation, Sterilization Validation, CIP/SIP, or similar activities.
• Experience preparing and executing validation protocols and final reports.
• Working knowledge of CIP/SIP systems, cleaning cycles, process parameters, and equipment operation.
• Strong technical writing and investigation skills.
