- Automation Engineer experience - specifically experience in Drug Product Automation preferable.
- in developing and maintaining process control automation solutions
- in leading/ supporting technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.
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Controls Engineer - Thousand Oaks, United States - ACL Digital
Description
Title: Principal Engineer/Controls Engineer / Automation Engineer
Location: Thousand Oaks, CA 91320
Duration: 12+ Months Contract
Basic Qualifications:
Doctorate degree
Master's degree and 3 years of Manufacturing Automation Engineering experience
Or
bachelor's degree and 5 years of Manufacturing Automation Engineering experience
Or
Associate degree and 10 years of Manufacturing Automation Engineering experience
Or
High school diploma / GED and 12 years of Manufacturing Automation Engineering experience
For 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:
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)
