Freshers Job – Sterilization Microbiologist Vacancy – Medtronic
In this exciting role as a Microbiologist-Sterilization II you will have responsibility for supporting on market product sterilization validations. You will have responsibility for sustaining sterilization work and to support of changes to existing products and introduction of new products. These validations include product sterilization validations, along with product and process validations. The position provides technical solution to achieve validated sterilization processes for new and existing products. Updates to routine sterilization procedures and related specifications. Supports and leads team with assessments of new products or changes to existing products.
Job Title: Microbiologist-Sterilization II
Location: Santa Ana, California, United States
Must-Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s degree in Science or technical field with 2+ years of work experience in microbiology and sterilization experience OR Advanced degree in science or technical field with 0+ years of work experience in microbiology and sterilization experience.
Nice to Have
- Strong leadership skill
- Project management experience
- Strong cGMP skills and knowledge of good documentation practices
- Good written and verbal communication skills, communicating clearly and concisely, both orally and in writing
- Proficient in Math skills, especially in Microbiology/Sterilization Science math formulas and calculations
- Computer literate with focus on LIMS, Excel, Word, Power Point and Project
- Good in statistical techniques
- Presentation skills
- Knowledge of laboratory safety
- Demonstrate good documentation practices.
- Knowledge of GMP, ISO 9001:13485 and MDD
- Knowledgeable in sterilization methods such as ISO 11135, ISO 14644 series, ISO 17665, ISO 14160, and microbiological test methods.
- Expertise in microbiological identification methods
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Work relatively independently with guidance and direction from senior members of the staff and manager.
- Assure all Quality requirements are in compliance with regulations and product specifications
- Provide new product development sterilization / microbiology validation support
- Perform, coordinate, execute, and summarize all areas of sterilization validation (EtO, Steam, and Liquid Chemical sterilization)
- Work with little guidance to design and validate sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support.
- Work with little guidance to develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations within Medtronic.
Support internal and external audits
- Prepare written responses to regulatory questions
- Review engineering change orders.
- Resolve non conformances and implement corrective action
- Work with Facility Maintenance and other departments for any Sterilizer, CEA, or Lab improvement/corrective activities.
- Participate in special projects as assigned.
- Reviews Supplier Change Control (SCC) notifications for impact to sterilization/microbial testing.
- Actively involved with Purchasing department for microbiological technical expertise to the in the selection and certification of component vendors.
- Assuring that the Microbiology / Sterilization function is maintained per industry standards.