Senior Manager Engineering: Manufacturing Clinical Supply
Employment Type: Full-Time
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
Senior Manager Engineering: Manufacturing Clinical Supply
What you will do
Let's do this. Let's change the world. In this dynamic role you will ensure reliable equipment and facility performance by maximizing uptime and enabling integration of new technologies to advance Amgen's clinical and commercial product supply. The Sr. Manager will be responsible for staff development, leadership, technical direction, and strategy deployment for driving forward operational excellence in a broad array of Drug Product Equipment. Responsibilities include:
* Provide tactical as well as strategic management and leadership to provide operational support and project completion, mentoring, staff development, team productivity and efficient use of available resources. Planning support structures with internal/cross-functional teams for capital projects, goals and network initiatives execution. Providing input into department objectives and establishment of strategic direction within the Drug Product F&E team.
* Maintain and improve plant capability and equipment reliability in partnership with F&E and plant leadership, and other technical staff in the network with a focus on 'predict and prevent' systems failures and recurrence avoidance. Strategize asset lifecycle management and long-range plans for equipment Maintenance.
* Work with diverse groups (Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering) within the organization and drive new business processes to ensure continuous and sustained improvements.
* Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.
* Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects and implement.
* Ensure site readiness and compliance for internal audits, external agency audits, and partner audits. Ensure safety of all personnel during plant operations and engineering activities. Ensure that all staff are adequately trained and follow all GMP standards and procedures
* Ensure Business Continuity, identify gaps and develop/implement solutions to close the gaps.
* Develop and adhere to department budgets and spend for operational and capital expenses.
* Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation and support regulatory inspections and audits.
* 10% domestic/international travel
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.
* Doctorate Degree and 2 years of Engineering, Manufacturing or Operations experience OR Master's Degree and 6 years of Engineering, Manufacturing or Operations experience OR Bachelor's Degree and 8 years of Engineering, Manufacturing or Operations experience OR Associates degree and 10 years of Engineering, Manufacturing or Operations experience OR High School Diploma / GED and 12 years of Engineering, Manufacturing or Operations experience
* 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
* 6+ years' experience leading engineers or other technical professionals in a multi-tiered organization and directing the allocation of resources
* 12+ years' experience in an Engineering, Manufacturing or Operations environment
* 5+ years' experience in Biopharmaceutical operations
* Experience in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
* Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as filling, isolators, lyophilization, cappers, inspection as well as other equipment and utilities needed to support these processes like autoclaves, clean in place (CIP) systems, washers, tunnels, clean steam, water for injection, etc. Knowledge of SU systems and assemblies.
* Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
* Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and completion of capital projects
* Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
* Understanding of safety requirements working in a GMP Biopharmaceutical Production facility
* Understand regulatory trends in the industry. Direct experience with FDA or equivalent regulatory body
* Independent, self-motivated, organized, ability to handle multiple resource demands and prioritization, assess project efficiency, and skilled in communication, facilitation, and collaboration
* Great teammate prepared to work in and adopt a team-based culture that relies on collaboration for effective decision-making
* Strong leadership, technical writing, and communication/presentation skills
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
* Vast opportunities to learn and move up and across our global organization
* Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
* Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
If 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.