Mq&sa Senior Scientist 微生物质量及无菌保证高级研究员

Johnson & Johnson Johnson & Johnson · Pharma · Suzhou, Jiangsu, China

The Senior Scientist will support end-to-end contamination control and sterility assurance practices for new and commercial products in Global Orthopedics. Responsibilities include aseptic processing, cleaning, disinfection, sterilization validation, reprocessing, microbiological testing, environmental control, and water/air systems validation. The role also provides sterility assurance support for new product development, ensures compliance with regulations and standards, and assists with inspections and risk assessments.

What you'd actually do

  1. Sterility Assurance technical areas supported include:
  2. Aseptic processing, cleaning and disinfection requirements, sterilization validation (for EO, gamma, electron beam, moist heat, and dry heat processes), reprocessing, microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, endotoxin monitoring), environmental control and monitoring, water and air systems validation.
  3. sterility assurance support to new product development and launch, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories. Inspection and submission support and Health based risk assessment.

Skills

Nice to have

  • Compliance Management
  • Quality Control (QC)
  • Quality Control Testing
  • Quality Management Systems (QMS)
  • Quality Standards
  • Regulatory Environment
  • Process Oriented
  • Problem Solving
  • Report Writing
  • Continuous Improvement
  • Product Improvements
  • Issue Escalation
  • Business Behavior
  • Coaching
  • Data Savvy
  • Disruptive Innovations
  • Agility Jumps
  • Database Backup

What the JD emphasized

  • compliance to applicable regulations and standards