Senior Microbiologist
Senior Microbiologist
Posted on :
10-04-2025
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1 Vacancy
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Job Description
Work Flexibility: Hybrid
Travel Percentage: 10
What you will do:
- Lead new product development and/or changes to medical devices currently in the market for sterilization.Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
- Participate in design reviews by identifying risks associated with the product use and tracking how the design documentation and manufacturing process mitigate those issues throughout the development process.Lead/support NC and CAPA activities.
- Lead departmental initiatives including setting timelines and milestones.Review/approve product and process change control documentation and specifications.
- Support product transfers to other plants/facilities.Partner with cross functional teams including (RA AO Ops) to ensure business unit project timelines are met.
- Partner with team by contributing to the development maintenance and improvements of the policies and procedures related to sterilization.May support in the development review and approval of sterilization process and equipment validation/qualifications (IQ OQ & PQ).
- Act as sterilization subject matter expert to align to best practices benchmarking against industry leads and regulatory requirements.Lead root cause analysis problem solving and outofspecification investigations.
- Define validation activities (i.e. product adoptions testing plans etc..Train and guide team members junior to you and other functions in area of sterilization.
What we need:
Required:
- M.Sc. in Microbiology/Applied Microbiology/Biological Sciences or related discipline.5 years related experience medical device pharmaceutical or chemical industry.
- At least 2 years of experience in medical device industry.Knowledge of GDP ANSI AAMI ISO FDA and USP guidelines related to sterilization (i.e. ISO 17665 ISO 11137 ISO 11135 etc..
- Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation ethylene oxide (preferred) hydrogen peroxide moist heat or dry heat and be an expert in one of the techniques.
- Demonstrated ability to effectively communicate manage projects and influence as well as can prioritize and manage multiple tasks simultaneously.
Preferred:
- Ability and desire to work effectively in a fastpaced multidisciplinary team environment.
- Strong interpersonal skills including strong written and oral communication.Strong in critical and analytical thinking.
- Highly developed problemsolving skills.Demonstrated ability to write technical documentation.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.Demonstrated ability to work independently.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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