Senior Manufacturing Systems Engineer BASQBAS

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 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 Amgens 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 Amgens plan to be a carbon-neutral company by 2027.

Senior Manufacturing Systems Engineer: BAS/QBAS

What you will do

Lets do this. Lets change the world. As a Senior Manufacturing Systems Engineer you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.

In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust automation systems to operate the new plant. This includes sophisticated and challenging system automation initiatives that require understanding of various automation platforms integration between different platforms analytical problem-solving techniques project management lifecycle management and Operational Excellence.

• Maintain the Building Automation System (BAS)on Siemens Desigo CC.
• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
• Collaborate with business partners to understand how utility and building equipment systems automation can improve workflow and productivity. Synthesize requirements from clients customers or end-users to develop the best automation solutions.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Maintain detailed specification and engineering policies and procedures that affect multiple organizational units.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO)
• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
• Lead/support technical root cause analysis incident investigations and troubleshooting on utilities and building automation controls
• Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
• Handle Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support Troubleshooting Support to Plant and Mfg. Operations Utility systems Utility and BAS Administration Preventative and corrective maintenance and Automation System spare parts management
• Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently better and be more cost efficient.

What we expect of you!

We are all different yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications.

Basic Qualifications:

• High School Diploma / GED and 10 years of Engineering experience OR
• Associates Degree and 8 years of Engineering experience OR
• Bachelors Degree and 4 years of Engineering experience OR
• Masters Degree and 2 years of Engineering experience OR
• Doctorate Degree

Preferred Qualifications:

• Degree in Electrical Engineering or Computer Science Chemical Engineering or Biotech Engineering.
• Direct knowledge of BAS design experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software.
• Extensive understanding and background in programming design installation and lifecycle management of building automation controls PLC and field device/instrumentation technologies.
• Experience with Siemens Building Automation system Rockwell industrial automation hardware and systems ability to perform sophisticated troubleshooting activities with Amgen DTI System Integration using OPC Foundation Fieldbus Profibus and DeviceNet technologies.
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11 ASTM 2500 S88 and S95.
• Experience in Capital Project Lifecycle Management: Conceptual Design Scope and cost estimate development business case development detailed design engineering and validation documentation and project implementation.
• Experience with continuous improvements resulting in enhanced safety system reliability and productivity (e.g. cycle times and reduced plant utilities usage etc.)
• The ideal individual must be a self-directed excellent teammate ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership technical writing and communication/presentation skills.

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 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