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Engineer (Plant Utilities)

Employer
Amgen
Location
Holly Springs, North Carolina
Start date
Feb 18, 2024

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Engineer (Plant Utilities)Live

What you will do

Lets do this! Lets change the world! The Engineer System Owner will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production, as well as developing subject matter expertise to support operations upon start up.

Responsibilities include:
  • Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
  • Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order.
  • Ensure systems are installed and operating safety and in compliance with pertinent environmental health/safety practice, rules and regulations.
  • Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
  • Monitor systems to identify performance risks and implement risk reduction strategies.
  • Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
  • Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
  • Apply knowledge of Operational Excellence practices such as lean maintenance to drive continuous improvement.
  • Responsible for commissioning and qualification activities including automation checkouts, IQ, OQ, and PQ.
  • Participate in the system walk-down, ensure the closure of punch items and support the takeover of the system from the project team.
  • Perform job responsibilities listed above for Plant Utilities including but not limited to: HVAC Chilled and Heating hot water, compressed air, plant steam, process chilled water, vacuum, glycol and cooling tower water.
  • Ability to provide On-Call support coverage on weekends, on a rotating basis (during 24-7 operations)
Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The motivated professional we seek is a collaborative teammate with these qualifications.

Basic Qualifications:
  • High School Diploma / GED and 8 years of Engineering experience OR
  • Associates Degree and 6 years of Engineering experience OR
  • Bachelors Degree and 2 years of Engineering experience OR
  • Masters Degree
Preferred Qualifications:
  • Bachelors Degree in Chemical or Mechanical Engineering
  • 5+ years' experience in Biopharmaceutical operations/manufacturing environment
  • Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration, single use systems as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
  • Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
  • Experience working 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.
  • Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution 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.
  • Independent, ambitious, organized, able to multi-task in project environments, 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.
  • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
  • Ability for domestic/international travel.
Thrive

What 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.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
Apply now

for a career that defies imagination

Objects in your future are closer than they appear. 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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