IntePros is currently looking for a Sr. Associate Sterilization Engineer to join one of our growing medical device/manufacturing clients in Scottsdale, Arizona. The Sr. Associate Sterilization Engineer will be responsible for planning, organizing and leading the sterilization workstream in support of client’s products. The ideal candidate will drive technical sterilization solutions for pharmaceutical customers, work with cross-functional development teams. You will act as a subject matter expert for Delivery Systems sterilization and drive technical decisions which support client’s business objectives.
The individual will bring excellent analytical, engineering, and leadership talent to the Delivery Systems sterilization and packaging group. Serve as the principal resource to project teams to support all sterilization-related activities as it relates to research and development of health care products. Contribute to identification and selection of appropriate sterilization technology and management of sterilization validation efforts for products to assure the sterilization process is robust and compliant with regulations, standards and company policies and procedures.
Sr. Associate Sterilization Engineer Responsibilities:
- Responsible for the development and execution of sterilization strategies to ensure medical devices meet functionality and design standards.
- Perform risk assessments and validation studies to ensure the effectiveness and safety of sterilization methods and protocols.
- Develop, maintain, and update sterilization processes in compliance with industry standards and regulatory requirements.
- Work with R&D, Quality Engineering, and other departments to ensure product integrity during product introductions, sustaining changes, and transfers.
- Offer technical support and insight regarding sterilization processes and regulations to internal and external stakeholders.
- Analyze and monitor data to identify trends, driving improvements in sterilization processes.
- Identify, investigate, and resolve issues related to sterilization equipment and processes efficiently.
- Participate in audits to ensure compliance with regulatory standards, providing recommendations for continuous improvement.
- Train and mentor R&D teams on sterilization processes, procedures, and regulatory requirements.
- Oversee the commissioning, maintenance, and validation of sterilization equipment to meet operational and energy efficiency standards.
- Identify and drive process improvements initiatives and cost-saving opportunities related to sterilization systems.
- Manage regulatory filings and respond to inquiries from regulatory bodies concerning sterilization processes.
- Deliver progress reports and presentations to communicate activities and timelines to management and core team members.
- Adhere to client compliance and safety policies and procedures at all times.
Education
- Bachelor's in Microbiology, Biomedical Engineering, or Chemical Engineering or related engineering disciplines required
- Masters Degree in related field preferred
Sr. Associate Sterilization Engineer Work Experience:
- 5+ years of experience in development of sterilization, medical devices, or pharmaceuticals.
- Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities) required.
- Experience leading sterilization development workstreams from concept through commercialization.
- Experience in working under requirements of Quality Management System in a regulated environment.
- Must have effective problem-solving abilities.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Able to comply with the company’s safety policy at all times.
Travel Requirements
- 10%: Up to 26 business days per year
