Develop, validate, and provide support for sterilization, cleanroom, and contamination control related processes between various facilities, supporting testing and contract manufacturing.

Position Details:

• Full-Time - Monday to Friday Standard Business Hours
• Location(s): St Paul, MN (preferred) or Atlanta, GA
• Expected Travel: 10-15% domestic
• Anticipated salary range: $78,270 - $101,910
  
  

• Qualification/Support to controlled environments/cleanrooms.
• Assessment/Implementation of microbiological methods and risk-based sampling plans supporting sterility assurance including environmental monitoring.
• Evaluation of supplier and service providers which may impact sterility assurance of testing/products.
• Improvement to site environmental and sterility assurance procedures/practices including remediation (where necessary).
• Develop, validates, and implements controlled environment methods.
• Validation of cleaning and disinfectant agents for use in critical environments.
• Process development for establishing, maintaining, and operating with validated states impacting sterility assurance.
• Validation and requalification of steam and ethylene oxide sterilization modalities.
• Validation and requalification of dry heat depyrogenation modality.
• General microbiology support for testing/contract manufacturing.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Ability to work in a team environment and independently as required.
• Contributes to the overall operations and to the achievement of departmental goals.
• Perform job-specific tasks in compliance with applicable Regulations, International. Standards, and WuXi AppTec Policies and Standard Operating Procedures.

• BS Degree and 5+ years of experience or MS Degree and 3+ years of experience (Life Sciences or Engineering).
• Self-starter able to work under limited supervision and to handle complex problems.
• Excellent organizational and interpersonal skills, ability to communicate effectively with all levels of the organization.
• Working knowledge of FDA, EU, and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices.
• Demonstrated experience applying industry standards and best practices for development, validation, and continuous improvement of processes related to sterility assurance and/or contamination control.
• Ability to identify compliance gaps in sterilization-related documents and lead efforts to remediate gaps by planning, executing, and/or managing sterilization validations.
• Proficient in Oral & Written communication skills.
• Need to be able to read, write and understand English.
• Proficient in Microsoft (Excel, Word, Outlook).