Senior Sterilization Specialist
We are seeking a seasoned Senior Sterilization Specialist to serve as the global technical leader in sterilization process design, validation, and sustaining.
* This individual will play a crucial role in influencing the company's strategic and tactical directions through the application of technical leadership, knowledge, and expertise.
* The successful candidate will lead a team responsible for ensuring the qualification status of all sterilization processes, investigating process deviations and non-conformances, and analyzing the impact of changes to products and processes on sterility assurance.
* This person will drive projects related to sterilization process expansion and optimization of major magnitude and scope.
Key Responsibilities:
• Provide technical oversight and drive projects for continuous improvement in Sterility Assurance practices.
• Interact with external regulators and various levels of management, working across many functional areas.
• Collaborate cross-functionally with multiple divisions and functions including quality, regulatory, global supply chain, and R&D.
What we are looking for:
• Bachelor's degree with Engineering, Microbiology, Biology, Chemistry or related discipline.
• Minimum of 10 years of experience in a medical device industry with a GMP and/or ISO regulated environment.
• Minimum of 5 years of direct people leadership experience is required.
• Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.
• Demonstrated capability to lead and train a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity.
• Experience in interacting with Regulatory Authorities.
• Demonstrated competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
• Proven track record on trouble shooting microbiological and/or sterilization process non-conformances and out of specification test results and providing resolution to issues via robust CAPA.
• High level knowledge of standards including AAMI and ISO.
• Must be able to travel 20% of the time (domestic and global).
Preferred qualifications:
• Master's or PhD degree in Microbiology, Biology, Engineering or related discipline.
• Competency in additional technical areas such as reprocessing and microbiology laboratory operations experience.
• Experience with conducting technical assessments of in-house and contract sterilization processes or contract microbiological laboratories.
We recognize that nurturing a diverse and inclusive workplace helps us innovate and advance science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.