Senior Manufacturing Systems Engineer

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 Manufacturing Systems Engineer

What you will do

Lets do this. Lets change the world. In this vital role you will be part of Amgens most technologically advanced drug substance manufacturing plant. The facility continues to expand in size and advance with embedded new technologies and industry 4.0 capabilities facility wide.

As aSenior Manufacturing Systems Engineeryou will:

• 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 automation can improve workflow and productivity. Synthesize requirements from clients customers or endusers to develop the best automation solutions.

• 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 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.

• Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units.

• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.

• Ability to anticipate evaluate and resolve project issues delays and problems by using technical project management and business expertise. Manage multiple initiatives and priorities.

• 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 more cost effectively

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.

Basic Qualifications:

• Doctorate degreeOR

• Masters degree and 2 years of Manufacturing Process automation/Information system experienceOR

• Bachelors degree and 4 years Manufacturing Process automation/Information system experienceOR

• Associates degree and 8 years of Manufacturing Process automation/Information system experienceOR

• High school diploma / GED and 10 years of Manufacturing Process automation/Information system experience

Preferred Qualifications:

• Demonstrable experience in a manufacturing environment with ability in the Pharmaceutical or Biotechnology industries.

• Direct knowledge of Automation design experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as media harvest bioreactors chromatography vial filtration and ultrafiltration/diafiltration and integrating various OEM automation software packages.

• Extensive understanding and background in programming design installation and lifecycle management of manufacturing process controls automation and field instrumentation technologies.

• Experience with Emerson DeltaV DCS system Process Control Network design including network segregation and Process Control System Virtual Infrastructure design and implementation.

• Demonstrable understanding of GAMP software development lifecycle ANSI/ISAS88 and S95 industry standards and methodologies to establish a PCS and MES implementation and Systems Integration that meets Operations business requirements.

• Experience in Capital Project Lifecycle Management: Conceptual Design Scope and cost estimate development business case development detailed design engineering and validation documentation and project execution.

• Demonstrated handson experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.

• Position requires an indepth knowledge and handson coding experience of Emerson Delta V Platform in particular and on Rockwell FactoryTalk Rockwell PLCs. Aveva PI Data Historian knowledge is preferred.

• Kneat platformbased C&Q documentation development knowledge a plus

• The ideal individual must be a selfdirected team player ready to mentor and develop engineering staff and embrace a teambased culture that relies on collaboration for effective decisionmaking.

• Strong leadership technical writing and communication/presentation skills.

What you can expect from 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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts

• A discretionary annual bonus program or for field sales representatives a salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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. 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.

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