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Job Title


Controls Engineer


Company : ACL Digital


Location : Thousand Oaks, CA


Created : 2024-05-04


Job Type : Full Time


Job Description

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:● 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● 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.● 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.● 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.● 4+ years' combined experience with the following:• Rockwell Automation SCADA and PLC Platform.• Siemens SCADA and PLC Platform• iFix SCADA 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, ETHERNET/IP technologies.● Knowledge of ODBC and RDBMS interfaces.● 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: ● 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).● 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.● Lead/support technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.● 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.● Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen's goals● Maintain Data Integrity Assessments with the current Amgen and Industry standards● Collaborate with Amgen Drug Product Plant network to improve the automation design for ATO Drug Product Plant Operations.● Follow GMP and SOP to add/remove equipment from CEMS● Follow GMP and SOP to add/remove user access to CEMS and/or WIN-911.● Follow GMP and SOP to enable/disable alarms from CEMS and WIN-911 system.● Follow GMP and SOP to perform Preventive Maintenance activities including OS patching on CEMS & WIN-911 system.● Lead root cause investigation for any failures on CEMS and/or WIN-911 system.● Own and close deviations/CAPA within agreed upon timelines.● Day-to-day Operational Support including:● Participate in the 24 x 7 Onsite/On Call rotation.● 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● Drive true root cause investigations and resolutions by interfacing with equipment Vendors.● Business Process Improvements including departmental Standard Operating Procedures (SOP)