Controls Engineer

2 weeks ago


Thousand Oaks, United States ACL Digital Full time

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:

  • 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.

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)


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