Sr Mfg Systems Engineer

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 Manufacturing Systems Engineer

What you will do

Lets do this. Lets change the world. In this vital role you will be part of Amgens newest and most sophisticated final product assembly and packaging plant. The Final Product facility will not only feature the best inclass device assembly and packaging 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 carbonneutral company by 2027.

As a Senior Manufacturing Engineer at Amgen you will support the analysis design and implementation of automation and information systems solutions to meet business requirements. You will collaborate with crossfunctional teams to gather and document system requirements perform system testing troubleshoot issues and provide enduser support. Your attention to detail analytical skills and strong technical acumen will contribute to the successful delivery of IT projects and the continuous improvement of business processes.

Responsibilities:

• Technical support during Capital Projects implementation including documentation review approval technical advice troubleshooting.

• Willing to travel to other Amgen sites to support Capital Projects 50 including temporary shortterm relocations.

• Own the ongoing creation and roadmap for key manufacturing systems

• Collaborate with business partners and other technology professionals to develop deploy and maintain the latest advanced technologies in support of product manufacturing optimization

• Collaborate with the rest of the manufacturing network to incorporate lessons learned and share ongoing best practices

• Manage and/or support the of a varied portfolio of IS projects with appropriate portfolio planning resource and risk management and financial management for the portfolio.

• Work closely with the delivery and platform teams to ensure that the applications are aligned with standard city planning approved architectural and development guidelines

• Lead selected efforts to design build and develop rapid ProofofConcept (POC) automated solutions and services. Quickly and iteratively prove or disprove the concepts being considered.

• Collaborate with business partners to understand how automation can improve workflow and productivity.

• Synthesize requirements from endusers application architects and cybersecurity experts to develop the best automation solutions.

• Technical support to manufacturing operations

• Work closely with other business and IS Process Engineers to find opportunities to stop inefficient practices simplify business processes and codify into automated solutions and platforms

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 degree
OR
Masters degree and 2 years of Information Systems job experience in a GMP environment
OR
Bachelors degree and 4 years of Information Systems job experience in a GMP environment
OR
Associates degree and 8 years of Information Systems job experience in a GMP environment
OR
High school diploma / GED and 10 years of Information Systems job experience in a GMP environment

Preferred Qualifications:

• BS or MS in computer science engineering information systems or related field

• Industry experience with software development of key manufacturing systems such as Supervisory Control or Data Acquisition (SCADA) Systech FactoryTalk Asset Centre applications that support manufacturing preferably biotechnology pharmaceutical or related industry

• 5 years experience crafting developing deploying and operating automated solutions across SaaS Cloud Onprem and custom software developed platforms

• Experience with Industry 4.0 technologies

• Methods and technologies to support Manufacturing Data integrations (e.g. SQL Web Services/messaging data mapping)

• Data analysis and reporting experience by using analytics visualization and database technologies (OSISoft PI RtReports Spotfire Tableau)

• Handson experience with computerized systems including troubleshooting reliability and performance improvements

• Expertise with translating business requirements/user stories to technical requirements and recommend solutions for automation

• Willing and able to learn new technologies at a rapid pace

• Experience in supporting key manufacturing systems with 24x7 operations individually and with vendors

• Experience or solid grasp of current Good Manufacturing Practices (GMP) 21CFR Part 11 regulations change control validation.

• Experience with Agile Product Development delivery and SAFe practices

• Knowledge in Data Integrity and Security

• Comprehensive understanding of validation protocol requirements as well as knowledge of validation processes

• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.

• Organizational problemsolving as well as validation protocol and technical writing capability

• Proven track record of leading and executing crossfunctional projects.

• Strong teamwork excellent interpersonal and communication skills.

• Experience in working with thirdparty vendors and equipment suppliers.

• Ability to work in a highly regulated and everchanging industry.

• Ability to learn and rapidly adapt to new requirements in a fastmoving environment.

• A passion to deliver an excellent work product and develop others with an infective positive attitude!

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.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

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