Amgen
Senior Manufacturing Systems Engineer - Automation
Amgen, Thousand Oaks, California, United States, 91362
Join Amgen’s Mission of Serving Patients
At 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 Manufacturing Systems Engineer - Automation
What you will do
In this role as a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Automation team you will support Clinical & Commercial Drug Product 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:
Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Support projects focused on improving process equipment/utilities/facilities to integrate new drug product manufacturing technologies into clinical/commercial facility.
Support of capital projects involving the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity.
Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
Development of detailed specification, engineering documents, SOP and operating standards.
Ownership and administration of process control automation in a GMP regulated manufacturing setting.
Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.
Design and testing of automation based process equipment.
Support new product introductions or new technology introductions by performing engineering assessments and supporting engineering runs.
Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
High school diploma / GED and 10 years of Manufacturing Automation Engineering experience OR
Associate’s degree and 8 years of Manufacturing Automation Engineering experience OR
Bachelor’s degree and 4 years of Manufacturing Automation Engineering experience OR
Master’s degree and 2 years of Manufacturing Automation Engineering experience OR
Doctorate degree.
Preferred Qualifications:
B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.
Strong control system automation background focused specifically in design, installation, programming and validation of automated processes.
5+ years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
Knowledge of ASTM 2500, S88 and S95 techniques.
Batch processing a desired advantage.
Strong leadership, technical writing, and communication/presentation skills.
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
Experience in developing automation strategies for New Product Introduction and New Technology Deployment.
Preferred Experience using Lyophilizer System, Filling systems for Syringe and Vials and Building Management System.
Working knowledge of building automation systems, electronic batch records, PLC, OPC, Foundation Fieldbus, Profibus, Ethernet/IP and DeviceNet technologies.
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
5+ years’ combined experience with Rockwell Automation SCADA and PLC Platform, iFix SCADA Platform, Process Control Network design, and Virtual Infrastructure design and implementation.
What you can expect from us
As 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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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, 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.
#J-18808-Ljbffr
At 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 Manufacturing Systems Engineer - Automation
What you will do
In this role as a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Automation team you will support Clinical & Commercial Drug Product 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:
Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Support projects focused on improving process equipment/utilities/facilities to integrate new drug product manufacturing technologies into clinical/commercial facility.
Support of capital projects involving the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity.
Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
Development of detailed specification, engineering documents, SOP and operating standards.
Ownership and administration of process control automation in a GMP regulated manufacturing setting.
Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.
Design and testing of automation based process equipment.
Support new product introductions or new technology introductions by performing engineering assessments and supporting engineering runs.
Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
High school diploma / GED and 10 years of Manufacturing Automation Engineering experience OR
Associate’s degree and 8 years of Manufacturing Automation Engineering experience OR
Bachelor’s degree and 4 years of Manufacturing Automation Engineering experience OR
Master’s degree and 2 years of Manufacturing Automation Engineering experience OR
Doctorate degree.
Preferred Qualifications:
B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.
Strong control system automation background focused specifically in design, installation, programming and validation of automated processes.
5+ years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
Knowledge of ASTM 2500, S88 and S95 techniques.
Batch processing a desired advantage.
Strong leadership, technical writing, and communication/presentation skills.
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
Experience in developing automation strategies for New Product Introduction and New Technology Deployment.
Preferred Experience using Lyophilizer System, Filling systems for Syringe and Vials and Building Management System.
Working knowledge of building automation systems, electronic batch records, PLC, OPC, Foundation Fieldbus, Profibus, Ethernet/IP and DeviceNet technologies.
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
5+ years’ combined experience with Rockwell Automation SCADA and PLC Platform, iFix SCADA Platform, Process Control Network design, and Virtual Infrastructure design and implementation.
What you can expect from us
As 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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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, 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.
#J-18808-Ljbffr