PD Sr Engineer

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgens 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 driving PD business strategy activities and providing cross-functional tech transfer support.

• Lead 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
• Acts as manufacturing process subject matter expert to support quality partners and provides operational and engineering understanding to assess the overall capability to clear bioburden and their potential by-products
• Works cross functionally to support draft of microbial impact assessment utilizing risk-based approach.
• Perform trending of bioburden instances within manufacturing space and elevate concerning objectionable microorganisms
• Lead the generation, resolution and closure of PD 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
• Manage and mentor an engineer member
• Support ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations

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

• High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR
• Associates degree and 8 years of biologics process development, process engineering, or process validation experience OR
• Bachelors degree and 4 years of biologics process development, process engineering, or process validation experience OR
• Masters degree and 2 years of biologics process development, process engineering, or process validation experience OR
• Doctorate degree

• 5+ 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
• Independently motivated with successful ability to multi-task and work in teams
• Demonstrated leadership skills and decision-making experience
• Experience with managing
• Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes.
• Excellent oral and verbal communication skills, interact effectively with diverse internal and external stakeholders

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your…