EQVAL Group, Inc. 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.
The Microbiologist Analyst is required to support microbiological testing, environmental monitoring, and sterilization validation activities within a Medical Devices manufacturing environment.
This role involves ensuring compliance with regulatory standards, conducting essential laboratory testing, and maintaining accurate documentation to ensure product quality and safety.
Minimum Requirements: Bachelor's Degree in Microbiology or related field.
3-5 years of experience in microbiological analysis, ideally in the pharmaceutical or medical device industry.
Experience in microbiological testing, environmental monitoring, and autoclave operation.
Proficiency in SOP development and technical writing.
Fully bilingual in English and Spanish.
Key Responsibilities : Microbiological Testing : Conduct tests (bioburden, endotoxin, sterility) on raw, in-process, and finished products.
Environmental Monitoring : Perform microbial testing in clean rooms and production areas to ensure compliance.
Sterilization Validation : Support sterilization processes, including microbial challenge studies and review of validation data.
SOPs & Documentation : Create and update Standard Operating Procedures (SOPs), and ensure all lab documentation is GMP-compliant.
Bench Work & Process Improvement : Apply hands-on experience in bench work, observe processes, and recommend improvements.
Autoclave Operations : Operate autoclaves for sterilization and equipment preparation.
Knowledgeable of the industry standards and regulations, such as ISO, FDA, GMP, or GLP.
Project management skills required.
Fully bilingual (English and Spanish).
Good technical writing skills.
Interact with cross functional departments to obtain validation data.
Benefits: Dental insurance Employee assistance program Employee discount Health insurance Life insurance Paid time off Professional development assistance Referral program Schedule: 8 hour shift Day shift Monday to Friday Work Location: In person Powered by JazzHR