Sterility Assurance Scientist

  • Integra LifeSciences
  • Mansfield, MA 02048, USA
  • Jan 21, 2019
Job - Full time Aerospace engineering Astronomy Biology Computer Science Chemical engineering Engineering Health Science Life Science Mathematics Medical Sciences Chemistry Civil engineering Physics Psychology Social Science Teaching/Academics Technology Veterinary medicine

Description

Responsibilities

  • Maintains procedures and methodologies to cover sterilization programs
  • Gains and applies knowledge of FDA, ISO and EN sterilization and related microbiology standards and guidelines to all tasks
  • Supports technical assessments of contract sterilizers and laboratories
  • Ensures adequacy of contamination control measures at external suppliers
  • Provides training to procedural changes
  • Provides input on the resolution of sterility related non-conformances
  • Supports sterilization validations, cleaning validations, and supporting activities for all product families.
  • Works with product development to ensure timely and complete sterilization adoptions and validations of all new products.
  • 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 in sterile release, bioburden and dose audit, and environmental monitoring programs as necessary
  • Creates and finalizes validation protocols and report ensuring they are lear, 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.

Qualifications

  • A Bachelor Degree is required, preferably in Microbiology, Biological Sciences or Engineering
  • 1 – 3 years of experience in sterilization/microbiology, medical device, Pharmaceutical and or / food industry is required.
  • 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 Microsoft Office applications is required.
  • Ability to effectively work on cross-functional teams, interacting with a diversity of disciplines and locations, including international teams.
  • Experience writing standard operating procedures, protocols, and test reports is preferred.
  • Attention to detail. Excellent organizational and time management skills.
  • Must be able to work under pressure due to reporting deadlines.
  • Familiarity with basic quality tools and techniques.

Experience level of the applicant we want

Some work experience, Graduate