EQVAL Group is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others).
We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.
We are looking for a Subject Matter Expert (SME) Sterilization with Medical Devices or Pharmaceutical manufacturing experience preferred (7+ years).
Must possess a solid background in Validations for Sterilization Cycle changes and excellent Project Management to support site activities.
Education and Experience: Bachelor's degree in Engineering, Microbiology or similar discipline.
Minimum of 7 years of experience in the Medical Device and/or Pharmaceutical manufacturing environment with effective experience and knowledge in sterilization processes.
Responsibilities: Support Ethylene Oxide sterilization cycle validation, re-validation, and improvements.
Interpreting microbiological testing data, ensuring sterility assurance in medical device manufacturing, and applying relevant Oversee microbial monitoring and sterility assurance in medical device production.
Interpret microbiological data and implement procedural changes and remediation projects.
Manage projects related to sterilization and microbiological testing.
Apply risk management principles to microbial monitoring and sterility assurance.
Experience in Ethylene Oxide sterilization, bioburden, endotoxin testing, radiation sterilization, controlled environment monitoring and the ability to act as a subject matter expert in these areas.
Knowledge of relevant standards (FDA, ISO, AAMI, USP, etc.)
and regulations (ISO 13485, ISO 11137, etc.).
Experience in technical writing (e.g., protocols, SOPs, reports).
Strong organizational and communication skills.
Expertise in microbial test method validation and controlled environment monitoring.
Project management skills, including tracking milestones and using Microsoft Project.
Fully bilingual in English and Spanish.
Job Type: Full-time Benefits: Dental insurance Employee assistance program Employee discount Health insurance Life insurance Paid time off Professional development assistance Referral program Vision insurance Schedule: 8 hour shift Day shift Monday to Friday Powered by JazzHR