About the Company
Our client is a global leader in the medical technology industry, dedicated to developing innovative healthcare solutions that improve patient outcomes worldwide. Operating in a highly regulated environment, the organization combines scientific expertise, advanced manufacturing technologies, and rigorous quality standards to bring life-changing products to market. The company fosters a collaborative and international culture where innovation, compliance, and continuous improvement are central to its success.
Role Description
We are looking for an experienced Staff Scientist – Microbiological Quality & Sterility Assurance (MQSA) to provide technical leadership across microbiological quality, sterility assurance, aseptic processing, and sterilization programs within a global medical device environment. This role serves as a key subject matter expert supporting new product introductions, manufacturing operations, validation activities, regulatory compliance, and continuous improvement initiatives. Working across international sites and cross-functional teams, you will drive sterility assurance strategies throughout the product lifecycle while ensuring compliance with global regulatory and quality standards.
Key Responsibilities
- Lead microbiological quality and sterility assurance activities for new product introductions, product lifecycle management, and manufacturing operations.
- Act as the technical SME for aseptic processing, sterilization validation, environmental monitoring, contamination control, and water systems.
- Support and approve validation activities, including sterilization, microbiological test methods, cleanroom, utility, and environmental qualification programs.
- Provide technical leadership during investigations, root cause analyses, CAPAs, audits, inspections, and regulatory submissions.
- Collaborate with R&D, Quality, Manufacturing, Regulatory Affairs, and external partners to ensure compliant and robust sterility assurance strategies.
- Assess and support contract manufacturers, sterilization providers, laboratories, suppliers, and manufacturing sites through audits and technical evaluations.
- Drive continuous improvement initiatives related to microbiological quality, contamination control, and sterilization processes.
- Represent the organization in industry forums, standards committees, and scientific networks related to sterility assurance and microbiological quality.
- Deliver training, mentoring, and technical coaching to strengthen microbiological and sterility assurance capabilities across the organization.
- Support global manufacturing sites through risk assessments, validation programs, regulatory inspections, and compliance activities.
Requirements
- Bachelor’s degree in Microbiology, Biology, Engineering, or a related scientific discipline; MSc or PhD preferred.
- Minimum 8 years of experience within the medical device, pharmaceutical, or other highly regulated GMP/ISO environment.
- Extensive expertise in microbiology, sterility assurance, aseptic processing, and sterilization validation.
- Strong knowledge of sterilization technologies such as EO, gamma irradiation, electron beam, moist heat, dry heat, and aseptic processing.
- Experience with environmental monitoring, contamination control, cleanrooms, water systems, and microbiological testing.
- Proven experience leading investigations, CAPAs, risk assessments, and validation programs.
- Strong understanding of global regulatory requirements, GMP standards, ISO standards, and sterility assurance regulations.
- Excellent stakeholder management, communication, and influencing skills within international organizations.
- Ability to work effectively across R&D, Quality, Manufacturing, Regulatory Affairs, and external partners.
- Willingness to travel internationally and work onsite a minimum of three days per week.
58179
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