LL01-020524 Global Sterilization Specialist

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individuals committed to work under the highest ethics standards for the following positions:

• Global Sterilization Specialist

The Global Sterilization Specialist will ensure that all sterilization and work environment processes are in accordance with company guidelines and regulatory requirements. They must l have a strong, working understanding of sterilization within the medical device industry and related regulations. The role will operate with minimal supervision and be expected to identify, manage all Sterility issues and provide recommendations to improve existing processes. Provides active support to the global operation with sterilization issues.

Essential Functions & Accountabilities:

• Ensures Sterilization and Sterility processes comply with all global, regional and local requirements. Maximizes best practices to ensure standardized processes across all applicable regions.
• Provide guidance for bioburden monitoring, environmental monitoring, and environmental control room practices.
• Ensure company documentation related to sterilization and microbiological controls are maintained and updated for compliance with current regulations, standards, and industry best practices.
• Assist with training and orientation of other colleagues, as needed.
• Evaluate the impact of new or modified manufacturing processes on existing sterilization methods and validations.
• Ability to present findings as required to a variety of levels throughout the organization.
• Prepare comprehensive summaries, discussion of scientific data, reports of current state of the data related to sterilization and sterility assurance process.
• Performs gap assessment on area such as sterilization, and sterility assurance process.
• Compile reports to ensure the appropriate regulatory requirements are met and sterility assurance levels are maintained Prepare test strategy as needed for validations, engineering studies, stability studies, new product introduction etc.

Qualifications:

• Good working knowledge of ISO/CFR/FDA regulated industry/cGMP & GLP.
• Understanding of ISO17665-2006 and relevant associated standards.
• Knowledge in Autoclave validation
• Effective interpersonal skills
• Proactive attitude
• Problem solving ability.
• Project Management skills
• Time management skills
• Report writing skills.
• Ability to read and understand highly technical material.
• Competent in use of basic computer packages e.g., Word, Excel, and PowerPoint.

Experience:

• 3+ years of experience in engineering, sterilization/microbiology in the medical device industry

Education:

• Bachelor’s degree in microbiology, Biological Sciences or Engineering Required