Lead, Cleaning & Sterilization Validation

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

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