Senior Microbiologist

Stryker Group; Tijuana; Presencial; MXN 657,000 - 940,000; Jornada completa

Descripción de la vacante

A leading medical device company in Tijuana is looking for a Microbiologist to perform microbiological testing and ensure compliance with quality standards. The role requires a Bachelor’s degree in Microbiology, at least 3 years of lab experience, and bilingual proficiency in Spanish and English. Responsibilities include leading sterilization qualification processes and mentoring team members, offering a dynamic and compliance-focused work environment.

Formación

• Minimum 3 years of microbiology lab experience in the medical device or regulated industry.
• Hands-on experience in microbiological testing and environmental monitoring in classified areas.
• Experience in method and equipment validation/qualification.

Responsabilidades

• Perform and review microbiological testing and environmental monitoring in controlled areas.
• Lead and approve sterilization process and equipment qualifications.
• Prepare and approve technical reports and documentation for environmental monitoring programs.

Conocimientos

Microbiological testing

Quality standards compliance

Technical subject matter expertise

Bilingual Spanish and English

Educación

Bachelor’s degree in Microbiology, Biology, or related field

Descripción del empleo

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.