Process Engineer - Upstream

Career Category

Job Description

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 awardwinning 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.

Process Engineer Upstream

What you will do

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

• 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 engineeringbased 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 as vital to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and stay in sync 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 vital.
• 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 sophisticated 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 oncall 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 5 years of Engineering/Maintenance 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 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 nonconformances corrective and preventative actions and qualifications/validation
• Strong leadership technical writing communication/presentation skills and the ability to work with minimum direction.
• Proven interpersonal and facilitation skills and ability to work in a collaborative teambased environment.
• Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.
• Ability to function within crossfunctional teams and embrace a teambased environment.
• Experience applying engineering principles to the design and implementation of system modifications introduction of new processes and of capital projects
• Understanding of the 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 multitask in project environments and skilled in communication facilitation and collaboration.
• Great teammate prepared to work in and embrace a teambased culture that relies on collaboration for effective decisionmaking
• Work schedule flexibility as required to support 24/7 operations requiring occasional afterhours 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 wellbeing. 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 and make a lasting impact with the Amgen team!

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.

Salary Range