Microbiology Manager (Memphis, TN)

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

In this role, you supervise a staff of Laboratory Supervisor(s), Microbiology Engineer(s), Technician(s) and Contractors/Consultants in order to maintain the microbiology and sterilization program in Memphis and to ensure that the programs under microbiological control are properly implemented in compliance with corporate and regulatory requirements. You will all develop, implement, and oversee policies and procedures related to cleanrooms, microbiological control and sterilization to meet and maintain compliance with regulatory requirements and best practices; developing, maintaining and implementing validations of Memphis Smith + Nephew (S+N) sterilization processes including ethylene oxide and gamma sterilization.

The Microbiology Manager serves as a subject matter expert (SME) for regulatory and corporate audits and for technical support for Memphis in the areas of cleanroom control/validation, product sterilization and microbiological control.

What will you be doing?

• Write protocols, reports and specifications for compliance of microbiology and sterilization activities.
• Develop and oversee policies and procedures related to microbiology and sterilization for Memphis site including cleanrooms and sterilization to ensure that they are in compliance with corporate, QSR, ISO, and other regulatory compliance requirements.
• Oversee the validation and routine review schedules for cleanrooms, gamma and ethylene oxide sterilization and maintains files and records.
• Administer training for the Memphis team and facility on microbiology, sterilization and cleanroom control.
• Interface with sterilization suppliers to review processes, determine validation requirements, and coordinates the validation.
• Coordinate with Product Development as needed for design control documents related to cleaning and sterilization of instruments and implants.

What will you need to be successful?

• Education: Bachelor of Science in a scientific discipline with 5 years' experience in sterilization or microbiology for regulated products.
• 1+ years of experience managing people is required.
• Direct experience leading and executing sterilization validation activities for EO and gamma processing.
• A thorough understanding of the QSR and ISO regulatory environment.
• Ability to understand advanced mathematical concepts, e.g., probability, statistical inference, calculus, and algebra.
• Auditing skills a plus.
• Proficiency in Statistical Software
• Travel Requirements: 10% domestic

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/)
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew is committed to the full inclusion of all qualified individuals. As part of this commitment, Smith+Nephew will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed, please alert the recruiter if you are selected to move forward.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.