Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
This position involves extensive programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity
Primarily responsible for supporting manufacturing operations in Amgen's Building 7 facility, through effective troubleshooting and ensuring automated equipment uptime and reliability.
Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
Develop engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Application of mature engineering knowledge in planning and conducting projects.
Prompt and regular attendance to workplace
Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems, Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
Develop of detailed specification, engineering documents, SOP and operating standards.
Master's degree & 3 years of Automation experience in Pharmaceutical, Medical Devices or Biotechnology industries
Bachelor's degree & 5 years of Automation experience in Pharmaceutical, Medical Devices or Biotechnology industries
Associate's degree & 10 years of Automation experience in Pharmaceutical, Medical Devices or Biotechnology industries
High school diploma / GED & 12 years of Automation experience in Pharmaceutical, Medical Devices or Biotechnology industries
Degree in Mechanical, Electrical or Chemical Engineering
Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems
Experience with Tech Transfer, Process Design, and Commissioning
Experience with validation and change control methodology
Direct experience with regulated environments i.e. cGMP, OSHA, EPA including detailed understanding of cGMPs
Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture
In-depth knowledge on Rockwell Automation Platform and Allen-Bradley PLCs
Factory Talk & ControlLogix PLC Platform, FTView, FTBatch, and DeviceNet technologies
Knowledge of Mitsubishi PLC and ABB Robotics
In-depth knowledge in programing languages such as VBA
Familiarity with OSI PI Historian
Direct hands on experience with lifecycle management of Rockwell hardware and software infrastructure preferred
Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context
Ability to create, update and read P&IDs, instrumentation and electrical design packages including SDS URS IQ OQ and VSR among other engineering and validation documentation
Knowledge of ASTM 2500 ISA S88 and S95 techniques - Batch processing a desired advantage
Work schedule flexibility to support 24/7 operations, requiring after-hours engineering coverage
ISA Certified Automation Professional
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.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.