Senior Microbiologist
Senior Microbiologist
Posted on :
21-08-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Onsite
What you will do
- Perform and review microbiological testing (bioburden microorganism identification growth promotion endotoxins) and environmental monitoring in controlled areas ensuring compliance with applicable methods and quality standards.
- Ensure compliance with laboratory best practices good manufacturing practices and regulatory requirements for medical devices.
- Lead and approve sterilization process and equipment qualifications (IQ OQ PQ - Installation operational and performance).
- Develop and improve manufacturing processes for new and existing products; support product transfers.
- Act as technical subject matter expert and point of contact for suppliers in process development quality matters and process improvements.
- Review/approve change controls specifications and nonconformance documentation.
- Prepare and approve technical reports monthly metrics and documentation for environmental monitoring programs in controlled areas.
- Ensure laboratory equipment is qualified calibrated and maintained; qualify methods; train and mentor team members; support audits and comply with health safety and environmental (EHS) policies.
What you need
Required
- Bachelors degree in Microbiology Biology or related field.
- Minimum 3 years of microbiology lab experience in the medical device or regulated industry.
- Bilingual Spanish and English.
- Experience in method and equipment validation/qualification.
- Knowledge of applied microbiology microorganism identification and sterilization fundamentals.
- Hands-on experience in microbiological testing and environmental monitoring in classified areas.
- Understanding of industry quality standards and regulatory compliance requirements for medical devices.
Preferred
- Experience reviewing/approving biological indicators and sterility analysis; support for sterilization validations.
- Experience coordinating testing with external laboratories and managing associated documentation.
- Experience mentoring junior engineers or scientists.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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