Senior Engineer - Manufacturing Systems

Company: Amgen SA
Location: Thousand Oaks
Posted on: October 29, 2024

Job Description:

Join Amgen's Mission of Serving PatientsAt 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. 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 Engineer - Manufacturing SystemsWhat you will doIn this role as a member of the Amgen Manufacturing & Clinical Supplies - Facilities & Engineering (MCS-F&E) Automation team, you will support Clinical and Commercial Drug Substance plant operations. This includes complex and challenging system automation initiatives that require understanding of various automation platforms, integration between multiple platforms, analytical problem-solving techniques, critical thinking, project management, lifecycle management and Operational Excellence.Responsibilities include:

• Develop and maintain process control automation solutions applying DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), Supervisory Control and Data Acquisition systems (SCADA).
• Lead/support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
• Own change control records, CAPA records and deviations as it relates to Automation systems.
• Support functional area projects focused on improving process equipment, cleaning systems and utilities to ensure reliability of drug substance manufacturing facility.
• Lead and support new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
• 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.
• Support Review by Exception (RbE) functionality that includes product Batch records, cleaning, and sterilization systems, Audit trail and version control systems.
• Collaborate with Amgen Drug Substance Plant network to enhance the automation design for Drug Substance Plant Operations.
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.
• Day-to-day Operational Support including:
  • Direct Manufacturing Support required for Critical Operations.
  • 24 x 7 Onsite/On Call as required.
  • Troubleshooting Support to Manufacturing operations, cleaning systems, plant utilities and Building management system.
  • Automation System Administration.
  • Automation System Operating Systems (OS) security patching and HotFix assessments and rollout.
  • Daily manufacturing and engineering work center team meetings.
  • Preventative and corrective maintenance.
  • Automation System spare parts management.What we expect of youThe automation professional we seek will possess these qualifications.Basic Qualifications:
    • Doctorate degree
    • Or Master's degree and 2 years of Manufacturing Automation Engineering experience
    • Or Bachelor's degree and 4 years of Manufacturing Automation Engineering experience
    • Or Associate degree and 8 years of Manufacturing Automation Engineering experience
    • Or High school diploma / GED and 10 years of Manufacturing Automation Engineering experiencePreferred Qualifications:
      • Degree in Electrical Engineering, Chemical Engineering or Biotech.
      • Extensive understanding and background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentation.
      • Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Clinical and Commercial Drug Substance Plant Operations.
      • Familiarity with Upstream and Downstream unit operations.
      • Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems.
      • Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and efficiency related to Drug Substance Plant Operations.
      • Experience in Capital Project Lifecycle Management is a plus.
      • 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.
        • 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 usAs 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.
          • 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, including remote and hybrid work arrangements, where possible.Apply nowfor a career that defies imaginationJoin us.careers.amgen.comAmgen 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.
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Keywords: Amgen SA, Buena Park , Senior Engineer - Manufacturing Systems, Other , Thousand Oaks, California