This vital role will lead the Amgen global network with strategic direction for the Commissioning and Qualification program while contributing to activities within capital projects involving the planning, design, construction, and execution of manufacturing process equipment, facilities and utilities. You will lead the Commissioning and Qualification Network and partner with functions across the organization as well as external partners to deliver complex engineering projects efficiently and cost effectively while implementing highly innovative and ingenious solutions to support Amgens business needs.
The Director of Engineering Projects is responsible for the technical direction, leadership, strategy and support for a broad array of projects and processes with specific focus on Commissioning and Qualification. Amgen is searching for an experienced Commissioning and Qualification Director to lead the global network in driving alignment, delivering on program improvement, and advancing the use of digital technology. The Director of Engineering Projects for C&Q will be responsible for delivering all aspects of the program for all types of projects and equipment including facilities, utilities, drug substance, drug product and final drug product equipment.
The Director will deploy innovative approaches to improve quality, compliance, speed, cost, and resource allocation for the global program. This position will deploy internal and external benchmarking, share and incorporate best practices, cascade lessons learned, and partner with key stakeholders to further drive Commissioning and Qualification program value.
This position encompasses both a leadership role and a C&Q technical expert role within the global capital projects management team. The director shall provide day to day management and leadership including mentoring, staff development and work prioritization for a small team of direct and indirect reports. In addition, the director shall provide input into department objectives and establishment of strategic direction within the Global Capital Project Management team.
Key elements of the position will be to provide leadership and direction to the C&Q Network which includes advancing key initiatives as well as supporting the capital projects portfolio through front end planning, estimating, scheduling, assigning resources to projects and initiatives, C&Q planning, setting direction for the team, and then supporting teams on the implementation of the program. 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 commissioning and qualification program and execution.
The Director also owns multi-site Standard Operating Procedures and Commissioning and Qualification Templates and works closely with Quality to ensure compliance and continuous improvement. The position will also provide direct project engineering leadership for critical capital projects. 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.
This position can be located at the following Amgen sites: ATO, ABR, ADL, ARI, AMA, AML, AOH, ANC. The position requires the ability to travel up to 30% including overnight stays.
Other Responsibilities include:
- Assists Global Strategic Sourcing on scope of work definition of external contractors and reviews contractual documentation.
- Support identification of staffing for critical projects with suitably qualified resources and providing guidance and oversight on program implementation.
- Owns and maintains C&Q program Standard Operating Procedures and Templates
- For critical projects, may directly manage execution of commissioning and qualification aspects of projects including C&Q document preparation, execution, and daily coordination
- Front end planning for critical projects including resource planning, estimating, C&Q service provider Scope of Work, Bid Package Preparation, Service Provider selection
- Reviews engineering electronic documents to ensure that the commissioning & startup requirements are accounted for in the multi-site templates
- Drive alignment of Commissioning and Qualification requirements with Engineering and Construction teams to ensure all aspects are aligned with the program including adherence to engineering specifications, Receipt Verification, Third Party Inspection, Walkdown and Turnover Planning, Turnover Package Documentation, and Engineering Change Management
- Ensures Amgen staff and Contingent workers on the Amgen Commissioning and Qualification Program are up to date with C&Q training requirements
- Doctorate degree and 4 years of direct experience in Engineering, Commissioning & Qualification or a related technical discipline OR
- Master's degree and 8 years of direct experience in Engineering, Commissioning & Qualification or a related technical discipline OR
- Bachelor's degree and 1 years of direct experience in Engineering, Commissioning & Qualification 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
- Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
- Excellent communication skills
- Strong safety focused with a firm understanding of construction, start-up and commissioning safety
- Strong collaborator, problem solver and solution oriented
- Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team- based environment.
- Extremely organized and thinks strategically to support key business decisions
- Ability to manage multiple tasks and effectively set priorities
- Proven experience leading C&Q for capital projects
- Prior experience leading engineers or other technical professionals
- 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 and innovation to deliver value
- 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
- Represent Amgen with outside firms, technical societies and regulatory bodies.
- Ability to develop, implement and utilize tools to drive innovation in meeting business needs; establish measure and evaluate performance metrics, taking actions based on results
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.