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Principal Engineer, Process Technical Lead

As part of AMGEN’s volume driven growth at AMGEN Dun Laoghaire (ADL), the Corporate Engineering Teams Engineering Technical Authority is hiring a Principal Engineer (Process Lead) to lead the design and implementation of new Syringe Fill Line and Inspection Areas.

The Engineering Technical Authority (ETA) within Amgen Corporate Engineering leads the design for critical projects as well as provides technical expertise and direction across Amgen’s global operations network. This position is part of the ETA organization that includes Process Systems, Facilities and Utilities, Site Project Engineering, and other engineering technical functions. The Process Technical Lead will report to the Engineering Technical Lead for the project, who is also a member of the ETA.

The Process Technical Lead provides coordination and oversite to a team of internal Amgen engineers and process leads from the A&E as well as the suppliers of the process equipment. They provide review of all equipment design provided by the suppliers to deliver the design specs and detailed design reports as part of Amgen integrated project delivery approach. The project scope includes the design and construction of a new Fill Finish product suite as part of our existing facilities.

As part of this project, Amgen will have a strong focus on delivering a digitally enabled and sustainable facility aligned with our digital manufacturing strategy and our aggressive corporate sustainability goals. The successful Process Lead will have extensive experience in Filling Equipment, Automatic Inspection Equipment, Component Preparation and Formulation Area design, development, and implementation.

The Principal Engineer deploys engineering expertise from within the company (global and site-based experts) as well as expertise from our industry to optimize Amgen’s assets throughout their life cycle

• Planning: Translate business needs into engineering technology and design solutions. Lead analysis of alternatives and recommendations for technical solutions in major projects. Lead Engineering in development and execution of corporate initiatives, goals & projects.

• Design: Lead design and equipment selection of process equipment, utilities, laboratory and building systems to optimize quality and cost across the total life cycle of assets. Ensure appropriate use of technology, and adherence to standards/practices. Approve appropriate exceptions to Amgen standards and specifications.

• Construction: Provide engineering support during construction, resolve technical issues, and ensure project objectives are met. Ensure commissioning standards are developed and implemented during system qualification.

• Operations and Maintenance: Assist sites in troubleshooting, and remediation to prevent future occurrence throughout the network. Support the implementation of sustainable and digital solutions to advance performance.

The successful candidate must be willing to relocate to the project site for the duration of the projects. The position requires the ability to travel as needed to deliver the project including overnight stays. After the projects is complete, it is anticipated that this position would either transition to a technical/engineering role within the new production suite, or would move into a corporate engineering role with network wide responsibilities for either a specific technical area or providing technical leadership to a portfolio of projects.

Basic Qualifications:

• Doctorate degree and 6 years of direct experience in Engineering or a related technical discipline OR

• Master’s degree and 10 years of direct experience in Engineering or a related technical discipline OR

• Bachelor’s degree and 12 years of direct experience in Engineering or a related technical discipline AND

• Minimum 3 years of managing people in a multi-tiered organization and directing the allocation of resources

• Experience leading teams, projects, and programs

Preferred Qualifications:

• Extensive experience with Syringe Fill Line and Automatic Inspection Equipment design and delivery.

• Extensive experience in the delivery of capital projects as part of the design team

• Proven ability to provide direction and oversight to equipment vendors to deliver for the capital projects

• Experience in providing technical support to manufacturing facilities

• Proven experience and track record of compliance in a highly regulated environment

• Demonstrated ability to effectively lead and partner in a complex, matrixed organizations

• Successful deployment of continuous improvement methodologies (e.g., Lean, Six Sigma, Total Quality Management, Reliability Centered Maintenance, Root Cause Analysis tools, etc.)

• Demonstrated experience in selection of and implementation of design elements for improved sustainability.

Competencies:

• Leadership and planning capabilities to delivery critical projects and capabilities

• Capabilities to hire, develop and lead a diverse workforce

• 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, fire codes, electrical codes, OSHA, LEED, Energy codes, Mechanical codes, Boiler and Pressure Vessel codes) 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 measure and evaluate performance metrics, taking actions based on results.