Principle Scientist - Microbiology & Sterilization
RemoteMexico
Job Summary
Lead global microbiology and sterilization programs across multiple manufacturing sites by serving as the subject matter expert for environmental monitoring, contamination control, and sterilization validation. Drive complex technical investigations for microbial excursions, develop risk-based contamination strategies, and ensure compliance with FDA, ISO, and GMP regulations. Author protocols, support regulatory submissions, and mentor quality professionals while collaborating with global teams in the Dominican Republic, UK, Denmark, Slovakia, US, and Mexico. Requires 10+ years of experience in medical device manufacturing, with up to 10% travel to Reynosa and overseas assignments.
Required Qualifications
- 10+ years of experience in microbiology, sterilization, sterility assurance, or contamination control within highly regulated industries
- Significant experience supporting medical device, pharmaceutical, biologics, or healthcare manufacturing environments
- Proven ability to lead complex investigations, root cause analyses, and microbiological risk assessments
- Experience supporting multiple manufacturing sites and collaborating across global business functions
- Ability to thrive in a complex, fast-paced environment while delivering high-value results and driving business impact
- Strong leadership skills with the ability to prioritize competing demands and influence stakeholders at all levels
- Excellent written and verbal communication skills, with the ability to communicate complex scientific concepts clearly
- Fluent in English, both written and spoken
- Experience collaborating with global teams across the Dominican Republic, UK, Denmark, Slovakia, US, and Mexico
- Strong cross-cultural communication and relationship-building skills
- Background in quality systems, engineering, process validation, and continuous improvement methodologies
- Experience applying structured problem-solving techniques to complex technical challenges
- Proficiency with Microsoft Office applications, electronic document management systems, and quality management tools
- B.S in Microbiology, Biological Sciences, Biomedical Engineering, or related scientific discipline
- Master's degree with extensive relevant experience
- Availability to travel to Reynosa's manufacturing site
- Position may involve travel up to 10% of the time
- Overseas travel is expected
- Most trips will include overnight stays
- Remote working in Mexico
- May need to support global discussions in different time zones or impromptu audits
Desired Qualifications
- Spanish is a plus
- Experience within the Medical Devices industry is preferred
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