Sr Associate Sterilization Engineering (Scottsdale, Arizona, US) bei West Pharmaceutical Services, Inc.
West Pharmaceutical Services, Inc. · Scottsdale, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in Scottsdale
This is an onsite position requiring the team member to be onsite 5 days a week
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
In this 100% onsite role, you will be responsible for planning, organizing and leading the sterilization workstream in support of West’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 West’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.
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.
Travel Requirements
Physical Requirements
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.
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