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%