TECHNICAL LEAD – CLEANING & STERILIZATION

Weil Group, Inc; Juncos (PR); On-site; USD 120,000 - 170,000; Full time

Job summary

Weil Group, Inc. seeks a Technical Lead for Cleaning & Sterilization in a Biotech/Pharmaceutical setting.

You will direct Cleaning Characterization, Cleaning Verification, CIP/SIP, and sterilization qualification activities, and coordinate documentation and on-site field execution to meet protocols, acceptance criteria, and project requirements. You will develop and review protocols and final reports, evaluate equipment operations and process sequences, and drive corrective actions with

Qualifications

• 8+ years of validation experience in pharma/biotech.
• 5+ years in Cleaning Validation and Sterilization Validation, CIP/SIP.
• 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.

Responsibilities

• Develop the technical strategy for Cleaning Characterization and Sterilization Qualification activities.
• Develop and review Cleaning Characterization Protocols, Sterilization PQ Protocols, and their final reports.
• Evaluate equipment operation and process sequences related to cleaning and sterilization.
• Review CIP and SIP circuits and associated operating parameters.
• Identify product contact surfaces and perform surface area calculations as required.
• Coordinate and participate in field verification activities.
• Review cleaning and sterilization cycle results to confirm protocol acceptance criteria.
• Support RFU and sterilization conditional release activities.
• Provide technical support during discrepancy evaluations and deviations.
• Recommend corrective actions and recovery plans when required.
• Participate in AM/PM project meetings and coordinate technical task assignments.

Skills

Validation exp

Technical writing

Investigation skills

Education

Bachelor’s degree in engineering/biotech/chemistry

Job description

TECHNICAL LEAD – CLEANING & STERILIZATION

• Biotech/Pharmaceutical

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.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*