About the role:

Provides support to the Sterilization organization to facilitate efficient operations, to optimize existing processes, and to ensure that production, quality and regulatory compliance goals are met. Works cross-functionally to understand process impact on products, evaluate process development and validation, and ensures efficient and effective transfer of product into production. Develops new technology, products, materials, processes, or equipment with minimal supervision.  Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects.  Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.

Responsibilities:

• Initiates and completes technical activities leading to new or improved sterilization processes to meet strategic goals and objectives of the company.  Prepares reports, publishes, and makes presentations to communicate findings.
• Understands engineering principles theories, concepts, practices and techniques.  Develops knowledge in a field to become a recognized leader or authority in sterilization and applies this knowledge in leadership roles in the company.
• Applies technical knowledge to innovate, design, and develop processes and procedures.
• Assesses sterilization process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
• Executes and supports the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
• Supports technical reviews.
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., Technical Reports, FMEA’s, etc.)
• Writes and reviews experimentation and validation protocols and reports applicable to products and sterilization processes.
• May serve as a core team member or extended team member on new product projects or process improvement initiatives related to sterilization.
• Provides assistance and support to the sterilization operations, regulatory, and quality groups as required.

Qualifications & Requirements:

• 3-6 years of experience in roles related to Sterilization and Microbiology with BS degree, or MS degree in Microbiology, Biochemistry, or related discipline.
• Strong troubleshooting and problem solving skills
• Experience with IQ, OQ and PQ processes
• Experience with multiple industrial sterilization processes and modalities. Comfortable working with internal and external vendors.
• Strong technical knowledge of Ethylene Oxide Sterilization processes and equipment preferred.
• Demonstrated understanding of medical device regulatory requirements and quality system an asset.
• Pro-active, energetic, self-assured professional with high personal integrity and ability to collaborate, influence and develop positive interpersonal relationships