Sterility Assurance Scientist

The Sterility Assurance Scientist is responsible to provide support to the sterilization projects as well to the sterilization programs of the current validated products.  The Sterility Assurance Scientist manages and supervise the processes like sterilization validation protocols, sterilization assessments, dose audits, sterilization failure investigations  maintain quality system as per ISO13485:2018 and 21CFR 820.

MISSION: We partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world.

PRIMARY RESPONSIBILITIES:

• Develops implements and manages product sterilization methodology across multiple sites in support of legacy products and NPI programs.
• Maintains an intimate knowledge of all methods and types of sterilizing both medical devices, pharmaceuticals and combination devices.
• Leads the supplier/vendor selection process, as it applies to sterilization, and conducts onsite/remote supplier audits.
• Authors sterilization assurance validation protocols and reports in conjunction with contract sterilizers and labs in accordance with customer requirement.
• Creates and implements test methods to evaluate and ensure the safety of sterilized products
• Develops written procedures to control routine sterilization processing
• Provides training and guidance to site level personnel and documents training in accordance with site procedure.
• Identifies and elevates opportunities for preventive and corrective action, assist in implementing proactive programs that are plant specific, as well as corporate-wide in sterilization/microbial control
• Monitors change control of products, product transfers, processes, and facilities with regard to impact on sterilization and microbial control, by means of document change requests, audits, project participation
• Creates project plans, timelines and budgets to ensure sterilization project goals are achieved. Communicates with executive team and site leadership all progress and escalations.
• Maintains a complete understanding and compliance with the requirements of FDA, OSHA, EPA, and Viant Medical mandates regarding sterilization, microbiological quality control, and medical products manufacturing environments.
• Assures state-of-the-art methodology and results using documented procedures, equipment and accept/reject criteria of sterilization process and validation testing
• Establishes and maintains a routine internal audit program as well as evaluation/audit of contract sterilizers and laboratories, in conjunction with other business units
• Conducts or participates as needed in customer and regulatory body audits
• Interfaces between the laboratory and other areas of the company to ensure test reports are clearly written and Understood
• Other duties as assigned

 Skills/Competencies

• Experience in developing and managing sterilization validations and ongoing production in accordance with ISO/AAMI 11135,  ISO 11137-1,-2,-3, and  AAMI TIR 15, 16, 17, 28
• Knowledge of product testing methods according to the ISO 10993-7 and ISO 11737-1,-2.
• Well organized, able to multitask, prioritize and manage multiple deliverables.
• Excellent attention to detail and accuracy.
• Excellent analytical, technical and troubleshooting skills. Hands-on approach to problem solving.
• Demonstrated proficiency with Microsoft Outlook, Microsoft Project, and Microsoft Office applications.
• Highly self-motivated, focused, self-starter, willing to learn, and take up new responsibility and tasks.
• Ability to work independently and as a part of a team.

Requirements:

• Minimum Education: 
• Bachelor’s Degree in Engineering, Microbiology, Biology or equivalent.
• Minimum Experience:
• Minimum 2 years of work experience within the medical device or pharmaceutical in the Medical Devices Sterilization, Sterility assurance, and product testing.
• Knowledge & Skills:  
• Knowledge on FDA Quality System Regulation, Medical Device Directive, ISO 13485, process validation requirements, biocompatibility evaluation standards and other standards that apply to the design, development and sterilization of medical device.
• Knowledge of GMPs, ISO, USP and FDA regulations as they relate to laboratory operations and investigations and sterilization.
• Bilingual English/Spanish – is a plus (US candidate)
• Bilingual English/Spanish (CR candidate)
• US Visa (CR candidate)
• 25% travel