Senior Engineer Projects

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.

Senior Engineer Projects

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 equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up.

• Identify support and/or lead implementation of engineeringbased 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 qualification of equipment.
• Ensure systems are installed and operating safely and stay in sync with pertinent environmental health/safety practice rules and regulations.
• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
• Provide system guidance to identify performance risks and implement risk reduction strategies.
• Provide problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis investigations and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments implementing equipment modifications and supporting engineering runs.
• Developing and implementing testing strategies for new and existing equipment.
• Execute qualification protocols including commissioning qualification test protocols (CQT).
• Ensuring that all equipment adheres to industry standards and regulations.
• Analyzing and documenting test results and completing reports.
• Working closely with other members of the engineering team to troubleshoot any issues with equipment functionality.
• Conducting regular audits of equipment to ensure ongoing compliance.
• Providing training and guidance to other staff on equipment validation processes.
• Collaborating with suppliers and manufacturers to understand the operation of new equipment and its qualification requirements

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Engineering experience OR
• Associates degree and 10 years of Engineering experience OR
• Bachelors degree and 6 years of Engineering experience OR
• Masters degree and 4 years of Engineering experience OR
• Doctorate degree and 2 years of Engineering experience

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 equipment/systems such as cell culture reactors centrifugation chromatography viral filtration 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.
• General knowledge of plant utilities including plant steam heating hot water chillers cooling towers air compressors and electrical systems
• Ability to analyze problems develop and propose engineering solutions in a scientific manner using datadriven 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 nonconformances corrective and preventative actions and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications introduction of new processes and the oversight of capital projects
• Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement construction startup commissioning and qualification
• 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 teamwork
• Collaborative teammate prepared to work in and embrace a team based environment that relies on communication for effective decisionmaking
• Strong leadership technical writing and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations requiring occasional afterhours engineering coverage
• Ability for domestic/international travel

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