West Pharmaceutical Services · 2 weeks ago
Sr. Associate Sterilization Engineering
Scottsdale, AZ
Full-time
Onsite
Senior Level
5+ years expWest Pharmaceutical Services is a dedicated team focused on improving patient lives through innovative healthcare solutions. The role involves planning, organizing, and leading sterilization workstreams to ensure compliance and effectiveness in sterilization processes for medical devices.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
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
Qualification
Required
Bachelor's in Microbiology, Biomedical Engineering, or Chemical Engineering or related engineering disciplines required
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
Preferred
Masters Degree in related field preferred
Benefits
Relocation assistance
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
Chairman, President, and CEO
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2025-12-06
Company data provided by crunchbase