Associate Mfg Systems Engineer

Career Category Engineering Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year.

Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based.

If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Let’s do this. Let’s change the world.

In this vital role you will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the site’s Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance.

Provide support for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANC Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment Gain cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports) Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met Support site/network validation driven continuous improvement initiatives.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

• High school diploma / GED and 6 years of Manufacturing or Operations experience
• Associate’s degree and 4 years of Manufacturing or Operations experience
• Bachelor’s degree

• Technical writing and presentations skills to collaborate with technical and senior management staff
• Previous experience and proficiency using Kneat, CDOCs, Laboratory Inventory Management System and Pi Sample Management lifecycle experience
• Ability to gain expertise in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility
• Ability to gain expertise in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administration
• Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC)
• Demonstrated ability to read P&IDs
• Ability to…