- At Smith+Nephew, we design and manufacture technology that takes the limits off living.
- 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.
- 1+ years of experience managing people is required.
- Direct experience leading and executing sterilization validation activities for EO (ethylene oxide) 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
- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website )
- Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
- Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
- Hybrid Work Model (For most professional roles)
- Hands-On, Team-Customized, Mentorship
- Discounts on fitness clubs, travel and more
- Kindly provide your expected salary range for this role.
- Memphis, TN Required)
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Microbiology Manager - Memphis, United States - Smith & Nephew
Description
*Microbiology Manager (Memphis, TN)*Life Unlimited.
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.
* *Education*: Bachelor of Science in a scientific discipline with *5 years' experience in sterilization or microbiology for regulated products.
*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:
* *Work/
Life Balance:
* *Your Wellbeing:
* *Flexibility:
* *Training:
* *Extra Perks:
#Indeed
Job Type:
Full-time
Pay:
$105, $115,000.00 per year
Application Question(s):
Experience:
* in sterilization or microbiology for regulated products: 4 years (Required)
* managing people: 1 year (Required)
* sterilization validation activities for EO: 4 years (Required)
Ability to Commute:
Work Location:
In person