Amgen Automation Engineer in Thousand Oaks, California

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).

Responsibilities:

Lead and support of capital projects. Responsible for 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. Provide understanding of project life cycles.

Responsible for 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. Engage in, and process change control requests per established SOP and processes.

Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.

Design and test of newly installed and currently installed automation based process equipment. Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes 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

Work schedule flexibility to support 24/7 operations, including occasional after-hours engineering coverage.

Basic Qualifications

Master's degree or completed by December 2017 OR

Bachelor's degree and 2 years of Engineering experience OR

Associate's degree and 6 years of Engineering experience OR

High school diploma / GED and 8 years of Engineering experience.

Preferred Qualifications

B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.

Strong control system automation background focused specifically in design, installation, programming and validation of automated processes.

2+ years combined experience with the following product platforms: Emerson DeltaV DCS systems version 11 or above, 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.

Strong leadership, technical writing, and communication/presentation skills.

Experience in developing automation strategies for New Product Introduction and New Technology Deployment.

Direct experience in process control engineering and troubleshooting with unit operations such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration.

Cleaning systems: CIP's, COP's, Glass washers, and Autoclaves.

Working knowledge of building automation systems, electronic batch records, PLC, OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies, as well as HVAC, purified water systems (RO, WFI).

Experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.

Experienced in change control, nonconformance, corrective and preventative actions, and validation practices.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.