November 6, 2024

LabChemS Corp.

Añasco

CONTRACT & FULL TIME & TEMPORARY

Project Validation Specialist III

Project Scope
Provide support to CORPORATE STERILIZATION WORKSTREAM for efficient and timely completion of project related to sterilization area including, new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements , among others. Interprets microbiological testing data, monitors, and maintains the sterility assurance. SENIOR LEVEL professional/team player with advanced knowledge and experience. Relevant experience and sufficient knowledge and experience to serve as a subject matter expert in one or more of the following areas: Ethylene oxide sterilization validation and requalification, Bacterial endotoxin test method validation and monitoring, Bioburden test method validation and monitoring, Reusable Medical Devices, Radiation sterilization validation and dose audit management, Controlled environment monitoring.
Requirements
Bachelor’s degree in microbiology or similar discipline. Minimum of 7 years of experience in regulated environments with knowledge in sterilization processes. Experience conducting microbial test method validations and managing projects independently. Experience with controlled environment monitoring, bacterial endotoxin test method validation and monitoring, bioburden test method validation and monitoring, ethylene oxide sterilization, radiation sterilization and dose audit management. Working knowledge of applicable regulations and their interpretation within industry. Ability to track and manage projects. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Project Management and Microsoft Project skills. Fully bilingual (English and Spanish) SUBJECT MATTER EXPERTS IN STERILIZATION AREAS ARE HIGHLY ENCOURAGED TO APPLY.
About Us
Lab Chem S Corp (LCC) is a leading company in consulting services, laboratories and support resources for the medical and pharmaceutical device industries in Puerto Rico. Compensation is negotiable according to the educational background and experience of the candidate.
This is a Short-Term Temporary job that requires physical presence in manufacturing areas. Must live in Puerto Rico and is not eligible for relocation or travel benefits. Applicants must speak Spanish.
We will STRICTLY consider applications from candidates that LIVE IN PUERTO RICO, SPEAK SPANISH, have the educational background and the specific STERILIZATION experience required.
Temporary one year contract 1355
Job Types: Full-time, Contract, Temporary
Pay: $30.00 - $45.00 per hour
Expected hours: 40 per week
Schedule: