Senior Engineer - Formulation and Component Preparation
As part of AMGEN's volume driven growth, the Corporate Engineering Teams Engineering Technical Authority is hiring a Senior Engineer to support the design and implementation of new Formulation and Component Preparation areas as part of a new Fill Finish Facility.
About the Role
This position is part of the ETA organization that includes Process Systems, Facilities and Utilities, Site Project Engineering, and other engineering technical functions. The Senior Engineer will report to the Engineering Technical Lead for the project, who is also a member of the ETA.
Duties and Responsibilities
* Provide technical oversight to a team of internal Amgen engineers and discipline leads from the A&E as well as the suppliers of the process equipment.
* Review all equipment design provided by the suppliers to deliver the design specs and detailed design reports as part of Amgen integrated project delivery approach.
* Lead analysis of alternatives and recommendations for technical solutions in major projects.
* Support design and equipment selection of process equipment, 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.
* Provide engineering support during construction, resolve technical issues, and ensure project objectives are met.
* Ensure commissioning standards are developed and implemented during system qualification.
* Assist sites in troubleshooting, and remediation to prevent future occurrence throughout the network.
Requirements
* Masters degree & 3 years of Engineering experience OR Bachelor's degree or & 5 years of Engineering experience OR Associate's degree & 10 years of Engineering experience OR High school diploma / GED & 12 years of Engineering experience.
* Experience with Formulation and Component Preparation area Equipment design and delivery.
* 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
* 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.