PD Sr Engineer

** 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 SENIOR 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 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 escalate 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

** What we expect of you*
* 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.

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* Basic Qualifications:

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* + High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR

+ Associate's degree and 8 years of biologics process development, process engineering, or process validation experience OR

+ Bachelor's degree and 4 years of biologics process development, process engineering, or process validation experience OR

+ Master's degree and 2 years of biologics process development, process engineering, or process validation experience OR

+ Doctorate degree

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* Preferred Qualifications:

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* + 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

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Experience with biopharmaceutical processes including process technical documentation, process monitoring, or large-scale studies

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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

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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

** What you can expect of us*
* As we work to develop treatments that take care of others, we also work to care for your professional and…