Senior Automation Engineer
As a member of the Amgen Manufacturing & Clinical Supplies Facilities & Engineering (MCS-F&E)
Advanced Automation and Technology team you will support Clinical & Commercial Drug Substance
Plant Automation. This includes sophisticated and complicated system automation initiatives that require proven understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, critical thinking, project management, lifecycle management and Operational Excellence.Responsibilities:
- Develop and maintain process control automation solutions utilizing DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
- Support functional area projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug substance manufacturing technologies into clinical/commercial facility.
- Lead/support technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.
- Lead and support new product introductions (NPI) or 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 Amgens goals
- Maintain Data Integrity Assessments with the current Amgen and Industry standards
- Collaborate with Amgen Drug Substance Plant network to improve the automation design for ATO Drug Substance Plant Operations.
- Day-to-day Operational Support including:
- 24 x 7 Onsite/On Call: Day to Day Operational Support
- Troubleshooting Support to Mfg. Operations
- Automation System Administration
- Automation System Operating Systems (OS) and HotFix assessments and rollout
- Daily manufacturing and engineering work center team meetings
- Preventative and corrective maintenance
- Automation System spare parts management
- Business Process Improvements including departmental Standard Operating Procedures (SOP)
Masters degree and 3 years of Manufacturing Automation Engineering experienceOr
Bachelors degree and 5 years of Manufacturing Automation Engineering experienceOr
Associate degree and 10 years of Manufacturing Automation Engineering experienceOr
High school diploma / GED and 12 years of Manufacturing Automation Engineering experience
We are all different, yet we all use our outstanding contributions to serve patients. For Automation professional We seek has these qualifications:
- Degree in Electrical Engineering or Computer Science, 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 solving problems 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 Plant 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 leadership is a plus.
- The ideal individual must be a self-directed teammate ready to mentor, as well as, develop engineering staff and accept a team-based culture that relies on partnership.
- 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 teamwork.
- 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 Amgen IS.
- System Integration using OPC, Profibus, and DeviceNet technologies.
- Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.