Director Engineering, Amgen North Carolina

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Director Engineering: Amgen North Carolina

LiveWhat you will do

Lets do this. Lets change the world! In this role you will provide direction, management, planning and administration of Engineering and Maintenance resources for Amgen North Carolina (ANC), to ensure all facility and production requirements are met.

Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and high performing teams? If you have a passion for talent development and want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity.

Amgen, one of the worlds leading biotechnology companies is investing $550 million to build a new multi-product drug substance bio-manufacturing facility in Holly Springs, North Carolina, a bio-manufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability; aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.

The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities and office space. Amgen is targeting 2024 for site completion. Specific responsibilities include but are not limited to:

During construction phase:

• Initial focus of this role for 1-2 years will be to work closely with Capital Project Delivery team and Site Operations team in establishing long term operations strategy for this new site.
• Develop and implement long term strategy for engineering technical support for ongoing operations in collaboration with site functions including EHS, Manufacturing, Quality, Supply Chain, etc.
• Build out the site Engineering team structures, hire, develop and retain top talent. Build a culture that cultivates and rewards continuous improvement, creativity and innovation.
• Direct the engineering team with a focus on automation and manufacturing process system operations, change control, troubleshooting, and improvements.
• Development and implementation of long-range strategies, goals and objectives and associated budgets for all engineering activities and services including but not limited to supporting manufacturing, lab, facility, and utility operations.
• Institute supporting organization and business structures, including innovation and talent development
• Ensure that all equipment, systems, and facilities are designed for operations consistent with local and federal laws and regulations.
• Ensure Engineering programs and practices are aligned with cGMP requirements and current global regulations.
• Ensure that procedures are in place for cGMP activities and are followed by area personnel and contractors.

Post construction completion and turnover:

• Direct the ANC Engineering team in support of supplying uninterrupted utilities and process equipment to the ANC site meeting engineered specifications.
• Provide engineering systems owner support for the site automation and utilities plant systems. Manage an asset life cycle program supporting the long-range planning process in identifying system improvements and replacing EOL assets through a continuous improvement program.
• Set the strategy, priorities, and objectives for the engineering teams. Allocate and organize resources to deliver on goals and commitments. Deploy decision making to the right level.
  • Anticipate challenges the organization may face in the future.
  • Commits resources to build a strong innovation portfolio and capitalize on new business opportunities.
  • Analysis and accurate review of engineering / construction / maintenance cost forecasts against scope
• Identify ways to improve the Central Utilities process and lower the operational costs.
• Alert senior management of critical quality, compliance, supply and safety risks.
• Perform management responsibilities associated to organize, development, coaching, mentorship of the engineering team, as well as the performance evaluation of direct reports.
• Fosters a culture that is equipped to handle change and transformation effectively.
• Active integration into Amgen global networks to deliver value to the collective operations.

WinWhat we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic engineering professional we seek has these qualifications:

Basic Qualifications:

Doctorate Degree and 4 years of Engineering experience

or

Masters Degree and 8 years of Engineering experience

or

Bachelors Degree and 10 years of Engineering experience

And

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources.

Preferred Qualifications:

• 10+ years of engineering experience in the pharmaceutical/biotechnology/Engineering industry
• Strong experience with regulated environments (i.e., cGMP, OSHA, EPA)
• Direct experience in drug substance manufacturing, automation execution, utilities, equipment maintenance and operations
• Experience managing Calibration and Preventive Maintenance programs
• Experience handling Reliability and Asset Management programs
• Experience applying Root Cause Analysis techniques
• Experience in System Ownership within a Drug Substance Facility
• Experience identifying and implementing sustainability initiatives
• Knowledge in lean six sigma tools and/or Lean Maintenance experience with a continuous improvement mentality
• Proven effective communication, leadership, and escalation with excellent verbal and oral communication
• Demonstrated ability to build strong relationships across the network
• Negotiating, Budgeting, Goal setting and Capacity Planning/Inventory skills
• Demonstrated experience and ability to prioritize key areas of focus and proactive leadership involvement
• Strong leadership skills with knowledge of coaching and mentorship of people
• Knowledge of basic compensation system practices and methodologies
• Computer Proficiency (MS Word, Excel, PowerPoint, Maximo)

ThriveWhat you can expect of us

As we work to develop treatments that take care of others, we also 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

Apply nowfor 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.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.