Sector: Pharmaceuticals
⚙️Ref: 58179Temporary
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.