Senior Manufacturing Systems Engineer

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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-related conditions. As a member of the Amgen team, you’ll 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, you’ll 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

Let’s do this. Let’s change the world. In this vital role, as a member of the Amgen Manufacturing & Clinical Supplies (MCS) Facilities & Engineering (F&E) Automation team, you will lead technical projects supporting Clinical & Commercial Plant Automation programs and Capital projects, including complex and challenging automation initiatives that require proven understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, critical thinking, project management, product lifecycle management and Operational Excellence. You will require extensive understanding and background in process control & automation systems, capital construction projects, engineering projects lifecycle phases, and lifecycle management of process automation systems and technologies for Amgen.

Responsibilities include:

• Lead technical projects as automation technical lead on complex capital construction projects including lifecycle asset management projects.

• Collaborate with the site process engineering team to understand key process requirements, develop and maintain process control/automation solutions using DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) on Virtual Server infrastructure.

• Support functional area projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug substance & drug product manufacturing technologies into clinical/commercial facility.

• Lead/support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.

• Partner closely with the Capital project team to design, build, commission, and qualify new equipment and systems needed for MCS operations.

• Support Commissioning & Qualification efforts including Automation Installation Verification/Automation Checkout/Functional Testing.

• Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls

• Develop and maintain detailed specifications, Standard Operating Procedures, and Operating standards that impact multiple organizational units

• Develop domain expertise to support operations upon startup, focusing on manufacturing process automation

• Provide leadership and guidance to the Automation Engineering team supporting 24 x 7 and troubleshooting to Manufacturing & facility Operations

• Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen’s ambitious goals

• Maintain Data Integrity Assessments with the current Amgen and Industry standards

• Collaborate with Amgen Pilot Plants, Drug Substance & Drug Product Plant network to improve the automation design for Manufacturing & Pilot Plant Operations.

• Provide support to the capital project team with a strong focus on safety and on-time facility startup

• Provide mentoring to develop and accelerate site technical automation team capabilities.

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:

• Doctorate degree OR

• Master’s degree and 2 years of Manufacturing Automation Systems Engineering experience OR

• Bachelor’s degree and 4 years of Manufacturing Automation Systems Engineering experience OR

• Associate’s degree and 8 years of Manufacturing Automation Systems Engineering experience OR

• High school diploma / GED and 10 years of Manufacturing Automation Systems Engineering experience

Preferred Qualifications:

• Degree in Electrical Engineering 10or Computer Science, Chemical Engineering or Biotech Engineering

• Extensive experience with understanding and background in Emerson DeltaV Systems, Rockwell Automation SCADA & PLCs, PI, Virtual Server infrastructure - Design, Engineering, Configuration, Programming, Testing, Installation, Commissioning and lifecycle management of automation, and field instrumentation

• 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.

• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and efficiency (e.g. cycle times, and reduced plant utilities usage etc.) related to Drug Substance & Drug Product Plant Operations.

• Demonstrated hands-on experience in developing process control strategies for New Products

• Familiarity with Upstream and Downstream unit operations.

• 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.

• The ideal individual must be a self-directed standout colleague ready to mentor and develop engineering staff and adopt a team-based culture that relies on collaboration for effective

• Strong leadership, technical writing, and communication/presentation skills.

• Ability to perform independently, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.

3+ years’ combined experience with the following:

• Emerson Delta-V DCS system

• Rockwell Automation SCADA and PLC Platform.

• Electronic Batch Reporting Systems Design and implementation experience.

• Process Control Network design including network segregation

• Process Control Systems: Virtual Infrastructure design and implementation and ability to perform sophisticated troubleshooting activities with network & server infrastructure team.

• System Integration using OPC, Profibus, and DeviceNet technologies.

• Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.

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 well-being. From our competitive benefits to our collaborative culture, we’ll 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.

careers.amgen.com

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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. 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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