CIP Process Engineer

4 days ago

Holly Springs, United States BioSpace, Inc. Full time
Job Details

Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.

CIP Process Engineer

What you will do
Lets do this. Lets change the world. In this vital role you will the Engineer reports to the Senior Manager of the Process Engineering group. The position is responsible for providing daily Engineering support at the Amgen North Carolina site. Specific duties include:
  • Provide system ownership for process systems and equipment supporting operations at the site.
  • Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
  • Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems. Lead the development of a business case if required to support the completion of the project.
  • Develop equipment/instrument 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 comply 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.
  • Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems.
  • 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.
  • Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
  • Own investigations of abnormal conditions through Deviation and business processes.
  • Develop, coordinate, analyze, and present results for operational issues and engineering projects
  • Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.
  • Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements
  • Communicating with supervisor and support staff, highlighting issues and proposing solutions.
  • Work in a small group of engineers and/or technicians on an ongoing or project basis.
  • Provide technical support and issue resolution with 24x7 on-call support of Utility systems on a rotational based frequency (Support may be required outside of normal working hours including nights, weekends, and holidays).
  • Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
  • Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.
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 dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:
  • High school diploma / GED and 8 years of Engineering/Maintenance experience OR
  • Associates degree and 6 years of Engineering/Maintenance experience OR
  • Bachelors degree and 2 years of Engineering/Maintenance experience OR
  • Masters degree
Preferred Qualifications:
  • Experience with CIP, SIP, and Parts-washer processes/equipment
  • 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 troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, Clean Air generation and distribution, and CIP; and as well as other Plant Utility equipment needed to support these processes such as Chilled Water chillers, cooling towers, steam boilers, air compressors, etc.
  • Experience with equipment and facility control systems operation, logic, and troubleshooting.
  • 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
  • Strong leadership, technical writing, communication/presentation skills and the ability to work with minimum direction.
  • Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
  • Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.
  • 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
  • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.


What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

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

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.

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