Sr. Engineer - Drug Substance Engineering Technical Authority (ETA)

What you will do

In this vital role you will be responsible for planning, design, construction, operations and maintenance technical support of Amgen manufacturing infrastructure, worldwide. 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.

This position is in the Drug Substance Process Systems Engineering team with an initial emphasis on capital project support for the DS facility at Amgen-North Carolina (ANC). Subsequent responsibilities will include end-to-end engineering support for future projects and technical global network management. The successful candidate's role will include responsibilities as a process equipment engineering lead delivering on design, construction & commissioning for ANC. This individual will be responsible for the successful design, integration, commissioning & qualification of a subset of process equipment on the ANC2 project.

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 track changes to specifications and standards, and system configuration.

Design

• Ensure adherence 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 effectiveness standpoint.

Construction

Use their ETA network to provide engineering support during the construction process, including responses to RFIs, resolving complex 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 effectiveness, and reliability of systems.
• Assist the sites in system troubleshooting and take action as necessary 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 state-of-the-art 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.

Basic Qualifications

• High school diploma / GED and 10 years of Engineering experience
• OR Associate's degree and 8 years of Engineering experience
• OR Bachelor's degree and 4 years of Engineering experience
• OR Master's degree and 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 competing 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 Amgen's 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 utilize tools to drive efficiency in meeting business needs; establish measures and evaluate performance metrics.