Senior Engineer (Drug Substance Process Engineering) at Amgen

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Engineer (Drug Substance Process Engineering)

Live!

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for planning, design, construction, operations and maintenance technical support of Amgen Drug Substance manufacturing infrastructure, world-wide. The Engineering Technical Authority (ETA) is responsible for technical direction, leadership, guidance and support for a specific array of process systems within an area of responsibility, such as Upstream Processes, Downstream Processes, Fill/Finish, CIP/SIP, Utilities, HVAC, Packaging, Devices, etc. Through their team(s) of global and site technical subject matter experts, the ETA will leverage engineering expertise both in the company and industry to optimize the life cycle management of Amgens assets, and is accountable for performance and reliability across multiple sites.

This position is in the Drug Substance Process Systems Engineering team with an initial emphasis on capital project support for the Flexbatch DS facility at Amgen-North Carolina (ANC). Subsequent responsibilities will include end-to-end engineering support for future projects and technical global network management.

This role will include responsibilities as a process equipment engineering lead delivering on construction completion & commissioning for ANC. The individual will lead the commissioning of equipment for various unit operations as part of the project engineering team. They will be responsible for coordinating construction completion with project partners, leading commissioning & qualification functional testing, troubleshooting technical issues and ultimately delivering qualified equipment for the site.

• Planning: Working with clients, as appropriate (e.g. PD, Quality, Manufacturing), develop and specify engineering standards, specifications, equipment selection and design. Develop metrics to support procurement strategies for equipment, inventory management, spares and preventative maintenance. Manage and record changes to specifications and standards, and system configuration.
• Design: Ensure consistency to standards and good engineering practices. Lead design of new systems in support of projects and new technology deployment. Ensure designs optimize the total life cycle of the asset, from both a cost and efficiency standpoint.
• Construction: Use their ETA network to provide engineering support during the construction process, including responses to RFIs, resolving sophisticated technical issues and conflicts, supporting overall project objectives.
• Commissioning: Ensure commissioning and qualification standards are developed and used. Use their network to provide engineering support to commissioning and qualification.
• Operations: Support development of, or approve operation procedures for the safe, efficient and effective operations of systems. Review performance data and make recommendations for improvement of system operations. Support NC/CAPA investigations related to equipment failures.
• Maintenance: Support systems failure analysis, approve maintenance standards and techniques. Support and review reliability and failure data, and implement actions to improve efficiency, and reliability of systems. Assist the sites in system troubleshooting, and take action as vital to prevent future occurrence throughout network.
• Management: Lead their technical network. Makes use of expertise at the site and corporate levels for solving problems and deploying solutions across all sites. Identify and resolve issues and conflicts. Provide mentoring of other members in their network. Ensure technical decisions for assigned systems are optimized with those managed by other ETAs. Remain current on innovative for systems for adoption of new techniques and technology within Amgen. Represent Amgen with outside firms, technical societies and regulatory bodies.

This role involves travel up to 30% including overnight stays.

Preferred location for this role is Amgen-North Carolina (Holly Springs). Other locations may be considered for outstanding candidates who are open to significant travel to ANC for project support.

Win!

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The expert professional we seek is a self-starter with these qualifications.

Basic Qualifications:

• High school diploma / GED & 10 years of Engineering experience OR
• Associates degree & 8 years of Engineering experience OR
• Bachelors degree or & 4 years of Engineering experience OR
• Masters degree & 2 years of Engineering experience OR
• Doctorate degree

Preferred Qualifications:

• Demonstrated ability to lead the design of process equipment for new facilities and to balance contending factors to deliver equipment that meets process, quality and operability requirements.
• Financial acumen to deploy initiatives that add shareholder value.
• Excellent communications skills, strong facilitation talent, and executive presence to drive cross functional objectives across Amgens international network.
• Strong analytical skills to identify potential improvement opportunities.
• Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, asset insurance, etc.) to stay at the forefront of technology implementation.
• Knowledge of applicable regulations (e.g. cGMP, building codes, Boiler and Pressure Vessel codes, etc.), to ensure compliance. Represent Amgen with outside firms, technical societies and regulatory bodies.
• Ability to develop, implement and use tools to drive efficiency in meeting business needs; establish measure and evaluate performance metrics, taking actions based on results.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.