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Microbiology Sterilization I

Salinas, PR · Biotech/Pharmaceutical
We are seeking a meticulous and dedicated Sterilization Microbiologist to join our Quality Assurance team. In this critical role, you will ensure that our medical devices and products are free from harmful microorganisms, directly impacting patient safety and regulatory compliance. The ideal candidate will develop expertise in this area.

Responsabilities
Supports EO sterilization and microbiological testing within a regulated manufacturing and quality environment. Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program. Prepares, cleans, disinfects, and/or sterilizes instruments, materials, products, and/or supplies.
Follows protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.
Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary. Develops, validates, and implements controlled environment methods. Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation. May also be involved in establishing requirements for the transfer of methodology from R&D.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A – job at this level is focused on self-development.

Key Responsibilities
Microbiological testing, EO sterilization support, documentation, validations, cross-functional collaboration.
Must-Have Skills
• Knowledge of EO sterilization 
• Familiarity with FDA, ISO 11135, ISO 11737, and other relevant standards for sterilization and microbiological testing. 
• Experience managing sterilization day to day activities and cross-functional teams 
• Strong skills in documenting sterilization validations, protocols, and reports. 
• Ability to clearly communicate findings and collaborate with regulatory bodies, manufacturing teams, and R&D. 
• Fully bilingual.


Technical Skills
Microsoft Office; TrackWise; Agile


Education:  Bachelor’s degree in scientific discipline (entry-level acceptable) o years experience

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

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