Senior Validation Engineer

$78,270 - $101,910/Yr

WuXi AppTec - Saint Paul, MN

Full-time - Mid Level

Saint Paul, MN

Professional, Scientific, and Technical Services

About the position

The position involves developing, validating, and providing support for sterilization, cleanroom, and contamination control related processes across various facilities. This role supports testing and contract manufacturing, ensuring compliance with applicable regulations and standards. The position is full-time, with standard business hours from Monday to Friday, and is based in St Paul, MN (preferred) or Atlanta, GA. The expected travel for this role is approximately 10-15% domestically. The anticipated salary range for this position is between $78,270 and $101,910.

Responsibilities

• 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.

Requirements

• 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).