Associate Director – Engineering Technical Authority

Associate Director – Engineering Technical Authority

Requirements

• High school diploma / GED and 14 years of Engineering or related technical field experience OR
• Associate’s degree and 12 years of Engineering or related technical field experience OR
• Bachelor’s degree and 7 years of Engineering or related technical field experience OR
• Master’s degree and 5 years of Engineering or related technical field experience OR
• Doctorate degree and 3 years of Engineering or related technical field experience

Responsibilities

• 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 design and equipment selection to optimize quality and cost across the total lifecycle of assets. Ensure appropriate use of technology and adherence to standards/practices. Approve appropriate exceptions to Amgen standards and specifications.
• Provide engineering support during the construction process, including responses to RFIs, resolving complex technical issues and conflicts, and supporting overall project objectives.
• Ensure commissioning and qualification standards are developed and used. Use their network to provide engineering support to commissioning and qualification.
• Support the development of, or approve operational procedures for the safe, efficient and effective operations of systems. Review performance data and make recommendations for improvement of system operations. Support non-conformance and preventive action investigations related to equipment failures.
• Support systems failure analysis, and 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 the network.
• Lead their design teams and technical network. Make 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. Drive technical decisions within a project scope and networks standards that span the global networks. Remain current on state-of-the-art systems for the adoption of new techniques and technology within Amgen. Represent Amgen with outside firms, technical societies, and regulatory bodies.

Preferred Qualifications

• Bachelor’s or advanced degree in Chemical Engineering, Mechanical Engineering, or other engineering field with life science experience.
• At least 5 years working in Architectural & Engineering and Construction Management Companies during design and project execution.
• At least 5 years working in or supporting a biologics drug substance manufacturing facility.
• Leadership of multi-functional teams to implement design and driving rapid decisions up to executive levels.
• Strong understanding of Drug Substance process engineering and manufacturing unit operations.
• 15+ years of combined engineering experience including capital project design, with a consistent track record of delivering complex projects in a regulated environment.
• Extensive experience providing technical support to manufacturing processes, equipment, and facilities.
• Financial competence to deploy initiatives that add shareholder value.
• Excellent communication and interpersonal skills, with the ability to build strong relationships with team members at all levels of the organization and across Amgen’s international network.
• Ability to manage numerous projects simultaneously and deliver results in a fast-paced environment.
• 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.