Principal Manufacturing 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. 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.

Principal Manufacturing Technology and Information Systems Engineer

What you will do

Lets do this. Lets change the this vital role you will drive overall program success by applying program and project management principles to teams partnering with business and technology leaders to ensure comprehensive alignment and finding optimized ways to deliver efficiency and quality for our partners.

We are seeking a Principal Manufacturing Systems Engineer with solid leadership skills in any of Amgen Manufacturing locations in the US or Europe to join our Ops Technology Manufacturing & Engineering team to help drive productivity through the company using technology to unlock opportunities to stop optimize processes and then automate as appropriate. Are you someone that has extensive experience on the Operations technology (Aveva Pi DeltaV Rockwell MES) and Program Management to take progressive project management approaches. Are you eager to take your program management continuous improvement & SAFE-Agile financial management skills and use them in creative new ways to build groundbreaking Operation smart technologies that helps develop life-changing biotech medicines If so this may be the right place for you.

Responsibilities:

• Lead large capital project and product teams by fostering Agile delivery while operating within GMP manufacturing environments.
• Partner with site and global stakeholders to prioritize demand manage backlogs and balance local needs with global strategy.
• Accountable for financials resource planning vendor performance and delivery against scope schedule and quality targets.
• Drive global standards templates and best practices for large operations technology project and product design deployment lifecycle management and support to enable scalability and operational excellence.
• Ensure solution delivery meets GMP compliance data integrity electronic batch records and regulatory inspection readiness requirements.
• Lead cross-functional collaboration between site and corporate Operations Quality IT OT Automation Platform Owners and external system integrators.
• Own the global operations technology roadmap including upgrades standardization harmonization and site deployments aligned with business and regulatory requirements.
• Mentor and coach junior project managers or Scrum Masters.
• Present status updates and progress to senior leadership at various governance meetings.

A day in a life:

• You are leading from the front engaging with business functions across the company to help deliver core manufacturing systems.
• Partnering with strategy groups at Amgen and business partners to deliver initiatives.
• Lead a team of PMs Platform SMEs and communication resources to ensure structure in how the program operates.
• Drive financial compliance and adherence across the program through the various projects.
• Own the overall program roadmap and communicate program status and milestones to executive leadership.
• Ensure product teams operate in the spirit of Agile and have backlogs that are being managed optimally.

What we expect of you

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

Basic Qualifications:

Doctorate degree and 2 years of Manufacturing automation/Information systems leadership experience

OR

Masters degree and 4 years of Manufacturing automation/Information systems leadership experience

OR

Bachelors degree and 6 years of Manufacturing automation/Information systems leadership experience

OR

Associates degree and 10 years of Manufacturing automation/Information systems leadership experience

OR

High school diploma / GED and 12 years of Manufacturing automation/Information systems leadership experience

Preferred Qualifications:

• Program and project management and delivery experience around manufacturing core systems like Aveva PI DeltaV Rockwell Korber MES Digital Infrastructure and advanced digital smart technologies.
• Solid understanding of GAMP software development lifecycle ANSI/ISA-S88 and S95 industry standards and methodologies and 21 CFR Part 11.
• Fluent in Agile methodologies with respect to technology solutions their development and timelines.
• Experience as a Product Owner or Scrum Master is a must.
• Manage integration of OT platforms (MES PI data etc.) with core manufacturing and enterprise systems (ERP LIMS historians automation layers such as DeltaV and Rockwell and data platforms).
• Strong written and oral communication skills with scientific domain expertise to communicate effectively with various partners within the organization.
• Self-motivated individual with demonstrated ability to learn new concepts and technologies and work cross-functionally in teams both internal and external.
• Project finance experience.
• You will have a consultant attitude with the ability to clarify and control a diverse and shifting program lifecycle. Creativity and flexibility will be key components to excelling in this role.

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.

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 sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying 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.

Sponsorship

Sponsorship for this role is not guaranteed.

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