Principal Manufacturing Systems Engineer- Formulation and Filling

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Principal Manufacturing Systems Engineer- Formulation and FillingLive

What you will do

Lets do this. Lets change the world. In this dynamic role, the Principal Manufacturing Systems Engineer will ensure the success of Drug product manufacturing through an extensive understanding and solid background in engineering, configuration, programming, installation, commissioning, maintenance, and troubleshooting of process controls, automation, electrical devices, and field instrumentation technologies. The Principal Engineer will design, develop, and deliver innovative solutions enabling the advancement of Amgen Drug Product manufacturing processes.

Job Responsibilities include:

Provide technical leadership for Day-to-day operational shift support for Drug Product manufacturing. Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.

Experience with the following product platforms.

• Rockwell Automation Factory Talk & ControlLogix PLC Platform
• Siemens PLC & SCADA Platform
• GE Intellution iFiX SCADA
• Wonderware SCADA System

  Day-to-day Operational Support:

  • 24 x 7 Onsite/On Call: Day-to-Day Rotational Support
  • Trouble shooting Support to Mfg. Operations

    Be a Subject Matter Expert for Drug Product Filling lines by:

    • Establishing close working relationships with the Filling Line Original Equipment Manufacturers (OEMs) to better understand the equipment and Automation system design.
    • Leading advanced trouble shooting activities in partnership with the OEMs, Plant Engineering, & Maintenance teams to enhance manufacturing uptime through the highest reliability of filling lines to Manufacturing.
    • Responsible for driving continuous improvement in partnership with plant engineering, maintenance, and OEMs to drive operational efficiencies for the assigned filling line.
    • Responsible to maintain User requirements, Design & Engineering specifications, drawings, Data Integrity assessment, Periodic reviews & Spare parts management.
    • Responsible for collaborating within the Amgen network to learn, implement, and share Continuous improvement opportunities within the Drug Product manufacturing Amgen Global network.
    • Responsible for maintaining and providing support for the operations of the associated plant utilities (WFI, RO, Clean Steam, UPS power distribution, Manufacturing Information System network infrastructure) related to the assigned filling line.
    • Responsible for maintaining Amgen Enterprise Cyber Resiliency compliance through quarterly OS patching of automation systems, servers & workstations.
    • Executive presence & communication of automation topics in the simplest business language at various partner forums in the workplace: Daily plant Work Center Team (WCT) meetings, Weekly plant performance review, F&E WCT, & MCS SLT WCT, Purposeful Presence on the Floor (PPoF)
    • As System Owner, you are accountable for and responsible for providing the necessary support during the internal and external regulatory audits for the assigned filling lines.

      As System owner, provide Amgen User requirements to OEMs/System Integrators during the development of process control applications using Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), and Supervisory Control and Data Acquisition systems (SCADA), and development of Batch Reports using Manufacturing Execution System (MES) platform. Lead & implement Continuous improvement & Department Capital projects by developing the scope, budget, schedule, resource demand, develop & present the business case, obtain the management approvals, and communicate the progress to the key partners. Lead and support Capital projects. This role involves the application of automation engineering principles in the design, specification, construction, startup, commissioning, and qualification of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. Responsible for developing & maintaining Engineering Specifications, documents, drawings, and Standard Operational Procedures (SOP), including Administrative SOPs and Job Plans. Conversant with industry standards on quality and regulatory compliance requirements such as 21 CFR Part 11 (Data Integrity, User Security, System Disaster Recovery, Data Backup & Restore). As Automation System Owner, lead new product introductions or new technology introductions in collaboration with multi-functional teams by performing engineering assessments, leading implementation of automation system configuration changes, and supporting engineering & Performance qualification runs. Support a Safe working environment by aligning with all pertinent environmental health, safety & maintenance program practices, rules, and regulations.

      Win

      What we expect of you

      We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.

      Basic Qualifications:

      Doctorate degree and 2 years of Engineering experience

      OR

      Masters degree and 4 years of Engineering experience

      OR

      Bachelors degree and 6 years of Engineering experience

      OR

      Associate degree and 10 years of Engineering experienceOr

      High school diploma / GED and 12 years of Engineering experience.

      Preferred Qualifications:

    • Masters or Bachelors Degree in Electrical Engineering or a related field.
  • Experienced in the process automation field within the biopharmaceutical industry.
• Experience with Drug Product unit operations such as Lyophilizer, Vial & Syringe Filler, Vial Washer, Capper, Depyrogenation oven & Tray Loader.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

Apply now

for a career that defies imagination

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

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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.