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Senior Sterilisation Engineer - Medtronic Athlone

Medtronic


Location:
Merced, CA 95341
Date:
22-10-2020
2020-10-222021-02-12
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Job Details

Senior Sterilisation Engineer - Medtronic Athlone

Location:

Athlone, County Westmeath, Ireland

Requisition #:

20000EIX

Post Date:

Oct 19, 2020


MEDTRONIC

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations


OUR PURPOSE

At Quality in Medtronic, plc, we focus on living the Medtronic mission by striving without reserve for unsurpassed product quality, reliability and patient safety through effective, agile and compliant processes.


The Plant Sterilization Engineer/Microbiologist has the responsibility and authority to provide scientific support for microbiological evaluation of medical devices, processes and materials.


The position will be responsible for completion of sterilization validations(s) and cleanroom microbiological evaluations. The position provides technical guidance to engineers and /or project management. This position requires knowledge of ethylene oxide sterilization per ISO 11135 and the Microbiologist should have strong report writing skills


Come for a job, stay for a career!


A DAY IN THE LIFE OF THE SITE STERILIZATION MICROBIOLOGIST:


Manages the sterilization and microbiological testing necessary to meet manufacturing and regulatory requirements

Responsible for maintaining compliance to all regulations and standards relevant to job responsibilities

Manage technical projects from protocol development, laboratory testing, data analysis through final report generation

Manage environmental trending as required by regulations to ensure compliance for critical systems

Develops, validates, and implements controlled environment methods

Perform various microbiological or chemical evaluations encompassing USP/AAMI biological testing, ETO residuals and other alternative sterilization methods

Provides technical support for new product development and manufacturing processes related to microbiological quality

Meets and occasionally exceeds the duties and responsibilities of the job and of Medtronic Core Competencies

All activities must be performed in compliance with the Quality System


KEY SKILLS EXPERIENCE


Required Education

Bachelor of Science degree is required (Level 8). Masters degree in Microbiology or other life sciences is preferred.


Required Years of Experience

5+ years of medical device industry experience in microbiology and sterilization


Required Knowledge

General Maths, general and analytical chemistry knowledge

Microbiology laboratory skills

Knowledge of Ethylene Oxide Sterilization as per ISO 11135. This includes validations, re-qualifications, and routine production.


Desired/Preferred Qualifications

Knowledge of industrial microbiology, microbiological quality control, medical device sterilization methods, and medical device GMPs.

Knowledge of applied microbiological theory and practices including inactivation kinetics, and medical device sterilization methods.

Microbiology laboratory skills including volumetric measurement, media preparation, microbial enumeration techniques, autoclave operation and laboratory safety.

Basic maths, algebraic maths, with ability to calculate serial dilutions, scientific exponents, proportional concentrations and graphing skills.

Knowledge of Cleanroom environmental monitoring.

Computer skills

Good oral and written communication skills


Medtronic offer a competitive Salary and flexible Benefits Package
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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