PD Engineer

About the role

Join Amgens 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Responsibilities

• Part of the Process Validation & Business Strategy (PBS) team within Process Development Drug Substance Technology (PD DST) group at Amgens FleX Batch Biologics Manufacturing Facility
• Ensure process validation activities are performed in a consistent and controlled manner to support manufacture of drug substances
• Engage in early tech transfer activities and PD business strategy
• Support bioburden impact assessment and assess unit operation capability to remove microorganisms or potential by-products
• Provide operational and engineering advice as part of the overall assessment
• Support biopharmaceutical processes including process technical documentation, process monitoring, or large-scale studies
• Perform trending of bioburden instances within manufacturing space and escalate concerning objectionable microorganisms
• Provide guidance for the generation, resolution, and closure of deviations
• Support upstream and/or downstream process engineering teams for process monitoring or technical study activities
• Support ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations

Requirements

• High school diploma/GED and 8 years of biologics process development or process validation support experience
• Associates degree and 6 years of biologics process development or process validation support experience
• Bachelors degree and 2 years of biologics process development or process validation support experience
• Masters degree

Qualifications

• Basic Qualifications: Experienced scientific professional with 8+ years of biologics process development or process validation support experience
• Preferred Qualifications: 2+ years of experience in an Upstream (Cell Culture), Downstream (Purification), or process validation role supporting biopharmaceutical processes within regulated environments (i.e., cGMP)
• Strong and in-depth expertise of the operation of upstream or downstream manufacturing processes
• Experience with biopharmaceutical processes including process technical documentation, process monitoring, or large-scale studies
• Experience with bioburden impact assessments in cGMP biopharmaceutical manufacturing
• Experience in technology transfers, CAPA, and deviations
• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders

What We Expect Of You

• Experienced scientific professional with 8+ years of biologics process development or process validation support experience
• Basic Qualifications: Experienced scientific professional with 8+ years of biologics process development or process validation support experience
• Preferred Qualifications: 2+ years of experience in an Upstream (Cell Culture), Downstream (Purification), or process validation role supporting biopharmaceutical processes within regulated environments (i.e., cGMP)
• Strong and in-depth expertise of the operation of upstream or downstream manufacturing processes
• Experience with biopharmaceutical processes including process technical documentation, process monitoring, or large-scale studies
• Experience with bioburden impact assessments in cGMP biopharmaceutical manufacturing
• Experience in technology transfers, CAPA, and deviations
• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders