Sr Engineer I- Instrumentation

What you will do

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.
• Provide troubleshooting support to reduce production downtime, including leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• 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.

Basic Qualifications

• High school diploma / GED and 10 years of Engineering/I&C experience
• Associate’s degree and 8 years of Engineering/I&C experience
• Bachelor’s degree and 4 years of Engineering/I&C experience
• Master’s degree and 2 years of Engineering/I&C experience
• 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.