Senior Process Engineer

** HOW MIGHT YOU DEFY IMAGINATION?*
* You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide.

Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company.

** Senior Process Engineer*
* ** Live*
* ** What you will do*
* Let's do this. Let's change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise and system ownership to support process operations, focusing on Downstream Process engineering.

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* Responsibilities include:

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* + Provide system ownership for Biopharmaceutical process equipment.

Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.

+ Effectively collaborate with key customers and support groups (e.g.Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.

+ Develop equipment maintenance programs, ensure the availability of spare parts, andcoordinatingmaintenance activities to ensure systems are in proper working order.

+ Ensure systems are installed and operatingsafetyand stayin syncwith pertinent environmental health/safety practice,rulesand regulations.

+ Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.

+ System guidance toidentifyperformance risks and implement risk reduction strategies.

+ Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.

+ Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

+ Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.

+ Provide technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.

+ Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for theprocessequipment. 

+ Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments,identifyinggaps and owning their remediation, implementing equipment modifications, and supporting engineering runs.

** Win*
* ** What we expect of you*
* We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

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* Basic Qualifications:

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* Doctorate degree

OR

Master's degree and 2 years of Engineering experience

OR

Bachelor's degree and 4 years of Engineering experience

OR

Associate's degree and 8 years of Engineering experience

Or

High school diploma / GED and 10 years of Engineering experience

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* Preferred Qualifications:

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* + Bachelor's degree in Chemical or Mechanical Engineering

+ 6+years'of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment with a focus on Downstreamunit operations

+ Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.

+ Ability to analyze…