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Engineer: Downstream System Owner

4 months ago

Holly Springs, United States Amgen Full time

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: Downstream System Owner

Live

What you will do

Lets do this. Lets change the world. In this vital role you 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.

  • Provide job responsibilities listed below for Downstream Processing including but not limited to: Chromatography, Viral Filtration, and UF/DF
  • 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 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 vital to ensure systems are in accurate working order.
  • Ensure systems are installed and operating safety and align with pertinent environmental health/safety practice, rules and regulations.
  • Ensure vital commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as needed.
  • 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.
Win

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 leader 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
  • 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
  • Direct knowledge of design and resolving issues with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration 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 teamwork
  • Phenomenal teammate prepared to work in and embrace 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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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.