Microbiologist Engineer II
- San Rafael, Alajuela
- Permanente
- Tiempo completo
Location: San Rafael, Alajuela, Costa Rica
Department: Quality
Reports to: Principal Microbiologist or QA Team LeadJob Summary:
The Microbiologist Engineer II will support microbiology and sterilization projects, including validation activities, cleanroom and environmental monitoring, and coordination with external laboratories and sterilization suppliers. This role ensures compliance with ISO 13485, 21 CFR 820, and other applicable standards, while supporting product release, audits, and continuous improvement initiatives.Key Responsibilities:
- Develop, review, and maintain quality documentation for microbiology and sterilization processes.
- Conduct supplier audits and review sterile release documentation.
- Write and review sterilization validation protocols and reports.
- Coordinate microbiology testing (e.g., endotoxins, sterility, bioburden, residuals).
- Analyze test results and ensure compliance with regulatory standards.
- Support new product introductions and changes impacting sterilization or microbiology.
- Lead or support investigations (NCRs, CAPAs) and cleanroom validations.
- Train personnel on procedures, specifications, and environmental controls.
- Participate in internal, external, and customer audits.
- Maintain microbiological trending, annual assessments, and change control reviews.
- Bachelor's degree in Microbiology, Biotechnology, Chemistry, Biology, or related field.
- Minimum 2 years of experience in the medical device, pharmaceutical, or similar regulated industry.
- Knowledge of ISO 13485, FDA QSR Part 820, ISO 11137, ISO 11135, ISO 11737, AAMI/ANSI ST72.
- Fluent in English (B2 or above).
- Strong documentation, organizational, and analytical skills.
- Proficient in Microsoft Office and Outlook.
ATL Technology is a global leader in custom interconnect solutions, specializing in the design, development, and manufacturing of medical devices and components. With operations across North America, Europe, and Asia, ATL partners with top-tier OEMs to deliver innovative, high-quality solutions that improve patient outcomes. Our Costa Rica facility plays a vital role in supporting global operations through advanced engineering, quality systems, and a commitment to excellence.Job Posted by ApplicantPro