PD Engineer

Amgen • Holly Springs, NC

22h • $88,281 - $119,439

About The Position

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. PD ENGINEER. What you will do. Let’s do this. Let’s change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen’s FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes development, support, and execution of process validation. The role will be responsible for ensuring process validation activities are performed in a consistent and controlled manner to support manufacture of drug substances. In addition, the role will be responsible for early engagement tech transfer activities and PD business strategy.

Requirements

• High school diploma / GED and 8 years of biologics process development or process validation support experience OR
• Associate’s degree and 6 years of biologics process development or process validation support experience OR
• Bachelor’s degree and 2 years of biologics process development or process validation support experience OR
• Master’s degree

Nice To Haves

• 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

Responsibilities

• Support bioburden impact assessment and assess unit operation capability to remove microorganisms or potential by-products and provide operational and engineering advice as part of the overall assessment
• Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to provide risk-based approach to microbial assessments
• Work cross-functionally to support microbial impact assessment drafts and documentation review
• 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
• Provide process validation support as required for documentation or floor activities
• Support ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level