The Director Engineering is responsible for technical oversight of Amgen infrastructure and engineering quality processes, world-wide. This position is for the Engineering Technical Director within the Engineering Technical Authority Organization serving as the Amgen recognized company Subject Matter Expert in the fields of Measurement, and Reliability.
Specifically, this position heads the Measurement and Reliability Engineering team with a primary responsibility as the engineering technical lead in support of Corporate Metrology, GMP Service Supplier Qualification and Global Asset Reliability.
Leading the development and implementation of corporate-wide calibration systems in support of the Amgen Metrology Standards Laboratory. Responsibilities included ensuring that primary measurement standards are kept in a state of statistical control and traceable to the SI via National Metrology Institutes. Ensure corporate standards laboratory is maintained in a validated state.
Provide Amgen with competitive advantage by leveraging the unique capabilities of the Corporate Metrology Standards Laboratory to resolve vital measurement challenges in multiple applications. Design and development of calibration/performance verification processes and provide training and engineering support to Site Instrumentation functions. Provide validation equipment and related SME support to Amgen clients conducting asset qualification in accordance with established protocols and schedules.
Global Network Leader and Corporate Quality Process Owner for maintenance and calibration processes. Frequently present programs to regulatory inspectors and internal auditors during inspections and internal/partner audits. Participate in cross-functional audit preparatory meetings and draft audit responses. Provide leadership responsibility for numerous Operating Standards, SOPs, Job Plans, Manuals and Training Qualification documents related to calibration and maintenance programs. Integrate existing and or newly acquired facilities into Amgen global Maintenance/Calibration programs.
Serve as the Business Owner for company-wide 3000 user validated global computerized engineering asset management system (Maximo). Coordinate multi-site implementation paper-less maintenance work order system. Ensures the delivery of system maintenance aspects including spare parts, Global calibration and maintenance job plans, etc. as part of project design. Assist sites in troubleshooting and take action, as necessary, to prevent reliability deficiencies throughout network.
Oversee the approval and qualification process of over 500 cGMP calibration and maintenance services providers spanning the complete breadth of the corporation. Ensure that Amgen's Quality requirements are being fulfilled through effective performance monitoring, quality agreement establishment and conducting supplier technical audits/assessments.
Serve as Engineering Governance Lead for Rapid Microbial Methods Team implementing process analytical testing solutions for TOC/Conductivity, viable particulates in air and water, enzyme based luminescence technology, cell density and other new technologies.
Advance a diverse portfolio of technical projects with both direct and indirect leadership responsibilities. Make use of expertise at the site and corporate levels for delivering designs, solving problems and deploying cGMP solutions across Amgen sites including global deployment of thermal validation systems consisting of wireless data loggers and a wired thermocouple system for temperature mapping, validation and qualification of various applications and pipette calibration software and methodologies.
Identify and resolve issues and conflicts. Provide mentoring of other direct staff, network and Project team members. Engage the Amgen technical networks to ensure SME input into systems and processes.
As the Measurement and Reliability Engineering Lead, manages and provides technical oversight to external entities and represents Amgen with outside firms, technical societies and regulatory bodies.
This position will lead a geographically diverse team of engineers and technical staff members as part of the ETA Network and may have dotted line responsibility across many sites.
This role involves travel up to 30% including overnight stays.
Doctorate degree and 4 years of Engineering experience
Master's degree and 8 years of Engineering experience
Bachelor's degree and 10 years of Engineering experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
* 15 years of experience in a site and/or corporate engineering environment, with specific specialized expertise in Measurement and Reliability particularly focused on Primary Level Measurement Standards and Global Quality Process Ownership.
* 10 years direct technical staff management (safety, compliance productivity, budget, staff development, etc.)
* 5 years direct Measurement and Reliability project engineering (technical delivery) in support of calibration systems design and/or innovative technology project execution. Experience in executing engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, cost/benefit analysis).
* Certification as a QA Auditor.
* Experience working under a formal quality program such as: ISO 9001; ISO 17025; ANSI/Z.540.3
* Strong communication/presentation (including to executive management), relationship building, leadership and mentoring skills