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Job Description

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.

Director, Engineering

Live

What you will do

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 Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity.

Amgen, one of the world’s 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 Amgen’s 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 2025 for site completion.

Let’s do this. Let’s 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. Specific responsibilities include but are not limited to:

During construction phase:

• Initial focus of this role for 1-2 year 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 Technical support for ongoing operations and maintenance of installed systems and equipment including system setups for Maximo etc.
• Development and implementation of long-range strategies, goals and objectives and associated budgets for all site soft and hard services including but not limited to lab operations, housekeeping, cafeteria, site maintenance, calibration programs etc.
• Institute supporting organization and business structures, including innovation and talent development
• Ensure the Central Utilities are designed for operations consistent with federal laws and regulations.
• Ensure Central Utilities, Preventive Maintenance and Calibration programs 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:

• Be responsible for Amgen F&E staff and Service providers for ongoing site operations and maintenance.
• Direct the ANC Central Utilities systems and processes, responsibility for supplying uninterrupted service to the ANC site within specifications.
• Ensure the Central Utilities are operated and maintained consistent with federal laws and regulations.
• Ensure Central Utilities, Preventive Maintenance and Calibration programs 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.
• Management and Monitoring of maintenance services to Central Utilities plant systems through the Maintenance Work Order Program.
• Manage Site Energy and Sustainability process thorough a continuous improvement program.
• Identify ways to improve the Central Utilities process and lower the operational costs.
• Manage Central Utilities Asset Management process.
• Responsible for planning, developing, and maintaining the Central Utilities budget.
• 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.
• Selecting and on-boarding contracted personnel, ensuring there are an adequate number of personnel to perform the functions in accordance with cGMP requirements.
• Set realistic deadlines for achieving strategic objectives.
• Ensure others have the information, authority, and support needed to achieve objectives.
• Allocate organizational resources in alignment with strategic plans and priorities.
• Willingly makes tough decisions and difficult trade-offs on behalf of the organization.
• Anticipate challenges the organization may face in the future.
• Monitoring that different organization-level decisions are based on data and sound reasoning.
• Orchestrate organizational resources and activities to accomplish objectives.
• Commits resources to build a strong innovation portfolio and capitalize on new business opportunities.
• Build a culture that cultivates and rewards creativity and innovation.
• 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.
• Analysis and accurate review of engineering / construction / maintenance cost forecasts against scope

Win

What we expect of you

Basic Qualifications

Doctorate degree and 4 years of Engineering experience

or

Master’s degree and 8 years of Engineering experience

or

Bachelor’s 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.

We are all different, yet we all use our unique contributions to serve patients. The dynamic engineering professional we seek has these 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 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 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 an 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 the proactive leadership involvement
• Strong leadership skills with the knowledge of staff relations, coaching and mentorship of people
• Knowledge of basic compensation system practices and methodologies
• Computer Proficiency (MS Word, Excel, PowerPoint, Maximo)

Thrive

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

Apply now

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.

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