Senior Engineer
3 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Senior Engineer / System Owner (Utilities) - Reliability / Instrumentation / Controls
Live
What you will do
Let's do this. Let's change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. Additionally, you will develop subject matter expertise to support operations upon start up.
- Provide system ownership for Instrumentation and Control of equipment, and supporting operations at the site, including manufacturing and lab equipment.
- Provide engineering support for design, construction, startup, commissioning and qualification of instrumentation and controls for new or modified systems.
- Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable items.
- Partner with Automation Engineers, equipment System Owners and maintenance technicians in identifying and solving field communication issues.
- Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, efficiency, or other unique capabilities to Amgen manufacturing.
- Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the Instrumentation and Controls or facility systems. Lead the development of a case if required to support the completion of the project.
- Support development of Calibration programs, ensure the availability of spare parts, and coordinate maintenance plan as vital to ensure systems are in accurate working order.
- Ensure systems are installed and operating safely and align with pertinent environmental health/safety practice, rules and regulations.
- Ensure vital commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as vital.
- Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process instrumentation systems.
- Monitor systems to identify performance risks and implement risk reduction strategies.
- Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)
- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
- Advance the use of condition based and predictive maintenance practices by incorporating sophisticated data analytics where applicable.
- Own investigations of abnormal conditions through Deviation and business processes.
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 dynamic, flexible, and driven individual with these qualifications.
Basic Qualifications:
- High school diploma / GED and 10 years of Engineering/I&C experience OR
- Associate's degree and 8 years of Engineering/I&C experience OR
- Bachelor's degree and 4 years of Engineering/I&C experience OR
- Master's degree and 3 years of Engineering/I&C experience OR
- Doctorate degree
Preferred Qualifications:
- A bachelor's degree in Chemical, Mechanical, or Electrical Engineering.
- 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment.
- Hands on experience of design and troubleshooting instrumentation and controls for process equipment and utility systems in a GMP Biopharmaceutical Production facility.
- Experience with field wiring and communications of field equipment and in relation with process control system such as DeltaV, Allen Bradley PLC and/or Building Automation Systems.
- Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.).
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation.
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the carrying out of capital projects.
- Understanding of the process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation.
- Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
- Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
- Great teammate prepared to work in and adopt a team-based culture that relies on collaboration for effective decision-making.
- Strong leadership, technical writing, and communication/presentation skills.
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
- The ability and willingness to travel domestic and international.
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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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