Senior Microbiologist - Sterilization (Austin, TX)

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

The Senior Microbiologist - Sterilization collaborates with diverse cross functional teams to define and oversee sterilization control policies, procedures and testing activities to support sustaining and new product development. The incumbent is responsible for ensuring compliance with domestic and international standards governing cleanrooms, contamination control, and Ethylene Oxide, Moist Heat and Gamma sterilization.

What will you be doing?

The Senior Microbiologist - Sterilization is responsible for:

• Developing, implementing, and overseeing policies and procedures related to cleanroom, microbiological control and sterilization to meet and maintain compliance with regulatory requirements and best practices; developing, maintaining and implementing validations of N. Austin Smith + Nephew (S+N) sterilization processes including ethylene oxide, moist heat and gamma sterilization.

• The Senior Microbiologist - Sterilization serves as a subject matter expert (SME) for regulatory and corporate audits and for technical support for N. Austin in the areas of cleanroom control/validation, product sterilization and microbiological control.

• Responsibilities also include providing direct customer support for inquiries related to sterilization and microbiological control of Smith + Nephew Orthopaedic devices, performing quality audits of S+N suppliers associated with sterilization and microbiological control and interacting with other key areas of the company to ensure the necessary reports and documentation are issued as required by SN procedures, ISO and FDA requirements.

The Senior Microbiologist - Sterilization is responsible for site-wide compliance of the activities related to microbiology and sterilization control.

• Oversees the day-to-day activities of cleanroom and sterilization microbiology activities in the N. Austin facility and establishes project timelines as needed.

• Develops and oversees policies and procedures related to clean-rooms and sterilization to ensure that they are in compliance with corporate, QSR, ISO, and other regulatory compliance requirements.

• Responsible for developing and implementing sterilization product adoptions, procedures and policies and overseeing/performing validations of the sterilization processes.

• Oversees the validation schedules for gamma and ethylene oxide sterilization and maintains files and records.

• Administers training for the facility on sterilization and cleanroom control.

• Collaborates with sterilization contractors to review processes, determine validation requirements, and coordinates the validation.

• Coordinates with Product Development as needed for design control documents related to cleaning and sterilization of instruments and implants.

• Works with suppliers, management, Engineers, and Manufacturing Associates in the resolution of quality problems associated with microbiology, sterilization and cleanroom control

• Performs internal and external audits as needed associated with sterilization/microbiology activities

• Writes protocols and reports as required.

• Performs other duties as assigned.

What will you need to be successful?

Education:

• Bachelor of Science in a scientific field required

Experience:

• 5+ years' experience in sterilization or microbiology for regulated products

• A thorough understanding of the QSR and ISO regulatory environment.

• Requires organizational and time management skills

• Ability to understand advanced mathematical concepts, e.g., probability, statistical inference, calculus, and algebra.

• An ability to work independently.

• Excellent verbal and written communication skills.

• Travel Requirements: 10%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, 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 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.