Director of Engineering for Process Systems Engineering

Website AMGEN

Job Description
Director of Engineering for Process Systems Engineering
The Director of Engineer is responsible for technical direction, leadership, strategy and support for a broad array of systems with a focus in a specific area of Drug Substance Manufacturing Systems.  This position encompasses both a leadership/managerial role and a technical SME role within the process equipment and systems engineering team.  The successful candidate will lead a team of 6-8 Senior engineers within the Process Systems engineering team which includes Drug Substance, Drug Product, Final Drug Product and Process Support systems (Cleaning, Sterilization, Single use).  The candidate will also provide technical network leadership and expertise of a specific technical equipment area such as Upstream Processing, Downstream Processing, or Cleaning and Sterilization (or others).  Key elements of the position will be to provide leadership and direction to the process systems engineering team, including setting direction for the team, assigning resources to projects and initiatives, and then overseeing the work of the team.  The director with also own, develop and maintain standard equipment designs within the area of expertise and provide network leadership to drive alignment, solve problems and prevent issues within Amgen’s manufacturing network.  The position will also provide direct project engineering leadership for critical capital projects, as well as providing managerial oversight for a team of SMEs with similar responsibilities for other technology areas.  To accomplish Amgen’s objectives, the position will strongly partner with Manufacturing, Process Development, Quality, EH&SS and other functions as Amgen maintains our goal of best in class manufacturing to serve every patient every time.


The position is part of the ETA organization that includes Process Systems, Facilities and Utilities, Site Project Engineering, Maintenance and Metrology functions.  This position is part of Amgen’s Process Systems Engineering Leadership and the ETA organization leadership Team.


The Director 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. They lead a team of senior level engineers who act as network leads and project engineers at sites in support of Amgen facilities in worldwide, as well as leading a specific technical network focus area supporting the Amgen manufacturing network.


Specific system responsibilities would be in an area of Drug Substance manufacturing, either upstream, downstream or cleaning and sterilization systems.  A key aspect of this role includes ownership of Amgen’s specification and standard designs for equipment in the area of responsibility.  Through their team, and partners this manager is has responsibilities for:

Planning: Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical solutions in major projects. Publish and maintain engineering standards and specifications. Lead Engineering in development and execution of corporate environmental sustainability goals & projects.
Design: Lead design and equipment selection 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: Review performance data and recommend improvements for systems. Develop and approve maintenance standards and techniques. Assist sites in troubleshooting, and remediation to prevent future occurrence throughout the network.  Support the long-range plan for Maintenance.
Sustainability: Support Amgen’s environmental sustainability
Management: Provide day to day management and leadership including mentoring, staff development and work prioritization for a small team of process equipment engineering.  Providing input into department objectives and establishment of strategic direction within the Process Systems team.
This position can be located at the following Amgen sites: ATO (preferred), ARI, AMA, AML. The position requires the ability to travel up to 30% including overnight stays.


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 6 years of managing people in a multi-tiered organization and directing the allocation of resources
Experience leading teams, projects, and programs
Preferred Qualifications:

Proven experience leading design in support of capital projects
Prior experience leading engineers or other technical professionals
Professional Engineer license
Extensive experience providing technical support to manufacturing processes, equipment and 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.)

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, 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 measure and evaluate performance metrics, taking actions based on results
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.—California—Thousand-Oaks/Director-of-Engineering_R-119423

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