Senior Engineer - Drug Substance Process Engineering

Amgen • Holly Springs, NC

1d

About The Position

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. SENIOR ENGINEER - DRUG SUBSTANCE PROCESS ENGINEERING What you will do Let’s do this. Let’s change the world. 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. 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 Amgen’s 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 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 ANC1 Expansion project. They will work with key partners to coordinate the successful delivery of qualified equipment to 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 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.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees