SUMMARYThe Sterility Assurance Scientist is responsible for supporting activities that maintain compliance to the applicable regulations (FDA, Canadian Medical Device Regulations (CMDR), European Medical Device Regulation (EU MDR), ISO 13485, and ISO 9001) as they apply to sterilization. Additionally, ensure compliance to other applicable Contamination Control, Endotoxin, Sterilization, Cleaning and Microbial ISO standards. AAMI standard/reports and other guidance documents as required. Provides Sterility Assurance expertise to ensure the adequacy of activities and documentation in terms of regulatory compliance and technical soundness throughout the manufacturing system. This will be accomplished by working closely with Product Development, Packaging Technology, Regulatory Affairs, Operations and Quality organizations.
ESSENTIAL DUTIES AND RESPONSIBILITIES- Serves as a Subject Matter Expert for Sterilization across the company.
- Maintains and revises procedures and methodologies to cover sterilization programs across sites.
- Obtains and maintains knowledge of FDA, ISO, and EN sterilization and related microbiology standards and guidelines, for example knowledge on ISO 11137, ISO 11135 and environmental monitoring requirements.
- Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans
- Subject matter expert with regard to technical assessments of contract sterilizers and laboratories.
- Monitors and ensures adequacy of contamination control measures at external suppliers.
- Provides training to procedural changes.
- Provides guidance and input on the resolution of sterility related non-conformances
- Supports sterilization validations, cleaning validations, and supporting activities for all product families by setting company policy and direction for these activities.
- Works with product development to ensure timely and complete sterilization adoptions and validations of all new products including the introduction of new novel sterilization processes.
- Trains Product Development personnel in contamination control and sterilization requirements and procedures.
- Collaborates with Subject Matter Experts from other departments (i.e. Design Quality Engineering) to ensure a comprehensive approach to bring new and changed product into production.
- Assists sites as an expert consultant in sterile release, bioburden and dose audit, and environmental monitoring programs as necessary
- Creates and finalizes validation protocols and report ensuring they are clear, concise and compliant to work instructions and standards.
- Knows and follows all laws and policies that apply to the position, and maintains the highest level of professionalism, ethics and compliance always.
- Participate in audits and other compliance program-related activities.
- Executes other duties/responsibilities as assigned by manager.
DESIRED MINIMUM QUALIFICATIONS- A minimum of a Bachelor Degree is required. A Bachelor Degree in Microbiology, Biological Sciences or Engineering is preferred. Experience related to manufacturing and contamination control is preferred.
- Experience in sterilization/microbiology, medical device, Pharmaceutical and or / food industry is required.
- 10+ years of experience working with sterilization of medical devices or pharmaceuticals.
- Have working knowledge of ISO documents related to sterilization such as ISO 11135 and 11137.
- Familiar with government regulations and Industry guidelines for sterilization and microbiological control.
- Working knowledge of applicable software, particularly Microsoft Office applications is required.
- Strong collaboration and communication skills needed to effectively work on cross-functional teams, interacting with a diversity of disciplines and locations.
- Experience writing standard operating procedures, protocols, and test reports is preferred.
- Basic understanding of microbiology, chemistry and engineering.
- Strict attention to detail.
- Must be able to work under pressure due to reporting deadlines.
- Must be able to work with limited supervision.
- Strong written and oral communication and interpersonal (listening) skills.
- Familiarity with basic quality tools and techniques.
- Analytical and critical thinking skills are important.
- Excellent organizational and time management skills.
- Willing to work in an international team.
- Travel to other sites and offices domestically and internationally as required.
- Ability to travel 25%.
Salary Pay Range:
$81,650.00 - $112,700.00 USD Salary
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
