Title: Principal Engineer/Controls Engineer / Automation Engineer Do you have the skills to fill this role Read the complete details below, and make your application today.Location: Thousand Oaks, CA 91320Duration: 12+ Months Contract Basic Qualifications:Doctorate degreeMaster's degree and 3 years of Manufacturing Automation Engineering experienceOr bachelor's degree and 5 years of Manufacturing Automation Engineering experienceOrAssociate degree and 10 years of Manufacturing Automation Engineering experienceOrHigh school diploma / GED and 12 years of Manufacturing Automation Engineering experienceFor Automation professional We seek has these qualifications:â— Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotechâ— Extensive understanding and background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentationâ— Demonstrated hands-on experience in developing process control strategies for New Productâ— Direct knowledge of Automation design, experience in process control engineering and solving problems with GMP biopharmaceutical production facility equipment/systems and integrating various OEM automation software.â— 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 Product Plant Operations.â— 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.â— 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.â— Strong leadership, technical writing, and communication/presentation skills.â— Ability to perform independently, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork.â— 4+ years' combined experience with the following:• Rockwell Automation SCADA and PLC Platform.• Siemens SCADA and PLC Platform• iFix SCADA Platformâ— Electronic Batch Reporting Systems Design and implementation experience.â— Process Control Network design including network segregation.â— Process Control Systems: Virtual Infrastructure design and implementation and ability to perform sophisticated troubleshooting activities with Amgen IS.â— System Integration using OPC, ETHERNET/IP technologies.â— Knowledge of ODBC and RDBMS interfaces.â— Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.Top 3 Must Have Skill Sets: Automation Engineer experience - specifically experience in Drug Product Automation preferable.in developing and maintaining process control automation solutionsin leading/ supporting technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.Day to Day Responsibilities: â— Develop and maintain process control automation solutions utilizing Rockwell and Siemens Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).â— Support functional area projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.â— Lead/support technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.â— Lead and support new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.â— Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen's goalsâ— Maintain Data Integrity Assessments with the current Amgen and Industry standardsâ— Collaborate with Amgen Drug Product Plant network to improve the automation design for ATO Drug Product Plant Operations.â— Follow GMP and SOP to add/remove equipment from CEMSâ— Follow GMP and SOP to add/remove user access to CEMS and/or WIN-911.â— Follow GMP and SOP to enable/disable alarms from CEMS and WIN-911 system.â— Follow GMP and SOP to perform Preventive Maintenance activities including OS patching on CEMS & WIN-911 system.â— Lead root cause investigation for any failures on CEMS and/or WIN-911 system.â— Own and close deviations/CAPA within agreed upon timelines.â— Day-to-day Operational Support including:â— Participate in the 24 x 7 Onsite/On Call rotation.â— Troubleshooting Support to Mfg. Operationsâ— Automation System Administrationâ— Automation System Operating Systems (OS) and HotFix assessments and rolloutâ— Daily manufacturing and engineering work center team meetingsâ— Preventative and corrective maintenanceâ— Automation System spare parts managementâ— Drive true root cause investigations and resolutions by interfacing with equipment Vendors.â— Business Process Improvements including departmental Standard Operating Procedures (SOP)
Job Title
Controls Engineer