STERILITY ENGINEER SPECIALIST

Description

STERILITY ENGINEER SPECIALIST
An innovative company, which is one of the largest international Medical Device manufacturers worldwide, is currently seeking a Sterility Engineer. The position will be for a period of 6 months (good possibility of extension).

POSITION DUTIES & RESPONSIBILITIES:

• This position is responsible for implementation and management of sterility assurance and reprocessing cleaning. This position ensures compliance to the applicable FDA (QSR) regulations, Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001 as they apply to sterilisation and reprocessing cleaning.
• This position provides Sterility Assurance (SA), oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness throughout manufacturing system.
• Establish and maintain procedures, tools and methodologies to cover all SA programs
• Maintain knowledge of FDA & ISO sterilization
• Conduct technical assessments of contract sterilizers and laboratories
• Ensure sterility validations for all product families are maintained
• Ensure timely and complete sterilization adoptions and validations of all new products.
• Review all vendor sterility assurance validation protocols and reports
• Collaborate with corporate packaging and validation groups to ensure a comprehensive approach to bring new/changed products into production.
• Create, review, correct and release any documents to cover the company reprocessing program (e.g. Cleaning Program, Steam Sterilization Program).
• Support and ensure sterility validations (e.g. cleaning validation, steam sterilization validation) are remediated and following the current standards.
• Train PD, consultant and other personnel in basic cleaning, disinfection and sterilization procedures.
• Review external validation protocols and reports to ensure companies and regulatory requirements are met.
• Create internal validation protocols and reports.
• Ensure that all validations are in compliance with the current clinical reprocessing information given to the customers
• Review and analyse medical device drawings
• Other duties/responsibilities as assigned by manager.

PROFESSIONAL EXPERIENCE REQUIREMENTS:

• Minimum 2 years sterilization/microbiological experience in the medical device and/or pharmaceutical industry
• Hands on Sterilization Validation (Gamma) with full responsibility for Study's
• Good understanding of 14937 (Health care sterilization) & 11139 (vocabulary) & GAMMA
• Knowledgeable in applicable FDA (QSR) regulations, Medical Device Directive (MDD), ISO13485, ISO 14971 and ISO 9001.
• Well versed in government regulations and industry guidelines for sterilization (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices.
• Fluent in English and German Knowledgeable in applicable reprocessing program (e.g. Cleaning Program, Steam Sterilization Program).
• Knowledgeable in applicable Medical Device Directive (MDD), ISO13485, ISO 14971, ISO 9001 and FDA (QSR) regulations.
• Well versed in government regulations and industry guidelines for clinical reprocessing (e.g. EN ISO EN ISO 15883, EN ISO 17665, EN ISO 17664, RKI guideline, AAMI TIR 12).
• Knowledge in engineering drawing reading
• At least 5 years' experience in clinical reprocessing (cleaning, disinfection and sterilization).
• Well known with critical design features for clinical reprocessing
• Well known with identification of design features in a drawing

EDUCATIONAL REQUIREMENTS:

• BS Degree in Microbiology, Biological Sciences or Engineering
• You can expect a challenging and varied job in a multicultural environment.

If this is something you are interested in please send your CV and get in contact with me…

Best Regards