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West Pharma Sr Associate Sterilization Engineering United States, Arizona, Scottsdale 577604239
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Essential Duties and 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 West 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
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.
Physical Requirements
Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.
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