Senior Microbiologist

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

• Bachelor’s 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.

Travel Percentage: 10%