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Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living!
Every lifecycle has a start point, and Smith+Nephew's wound care products are no different. To bring a new product to market, there are many stages of testing, verification and validation to consider, and that comes after a concept is in place.
We have an exciting, new opportunity for a Microbiology Lead, to influence and play a part in our future, as our future facing products are invented and crafted. This unique opportunity will lead as a subject matter expert to run all activities related to the delivery of a new, microbiologically compliant facility, including the sterility assurance of finished products, sterilisation validation strategy and routine control both internally and at third party suppliers. You'll be at the forefront of how microbiology is conducted at S+N, now and in the future!
What will you be doing?
Project Management:
* Oversee all microbiological aspects of the project.
* Plan and phase activities to align with the project timeline.
* Provide continuous support to the project leader.
Documentation and Compliance
* Review and approve change control assessments, user requirements, and reports.
* Develop and maintain microbiological procedures and risk assessments.
* Ensure compliant operations during asset removal and installation at our Hull and Melton sites.
* Update sterilisation files for new manufacturing site.
* Provide audit-ready documentation for microbiological acceptance activities.
* Lead in microbiological audits.
Testing and Monitoring
* Plan and implement microbiology testing for cleanroom risk assessments and compliance.
* Determine and implement cleaning regimes for each project stage.
* Develop monitoring strategies for our new facility.
Communication and Collaboration
* Collaborate with engineers to ensure ISO 8 Cleanroom compliance and microbiological control.
* Advise on compliant practices for our new facility.
What will you need to be successful?
To be successful in this dynamic, project-based role, you will need a degree in microbiology or a related field, with experience in sterility assurance and cleanroom management. Proficiency in irradiation and Ethylene Oxide sterilisation modalities, with related national and international standards, is essential, whilst proven experience in cGMP for sterility assurance is also required.
What will really make you stand out is your understanding of cleanroom management, including cleanliness standards, and your ability to follow manufacturing guidelines. Practical experience with microbiological aspects of controlled manufacturing and familiarity with risk assessment tools are a huge bonus!
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 Growing on Diversity, Learn more about our Employee Inclusion Groups on our website
* Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.
* Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
* Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.
* Extra Perks: Discounts on Gyms and fitness clubs, Salary Sacrifice Bicycle and Car Schemes and many other Employee discounts.
Applications:
If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you.
We continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for Smith & Nephew, our customers and their patients.
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