Apply to Engineer Principal, Automation - (JP11856)

Job Title: Engineer Principal, Automation - (JP11856)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Advanced Technology and Automation
Duration: 1 year with likely extensions and/or conversion to permanent
Rate: $58-64/Hour (contingent on market)
Posting Date: 10/03/23

3 Key Consulting is hiring an Automation Principal Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Client is seeking a contract Principal Automation Engineer based in Thousand Oaks, California to augment our Automation team. This role will support Drug Product Assembly & Packaging equipment, Critical Equipment Monitoring systems (CEMS), and technology development projects within the Drug Product Automation team by maintaining and improving automation systems, new technology introduction, and critical site support. The successful candidate must exhibit sound analytical thinking and problem-solving skills, exemplary communication and collaboration, and operational excellence. A proven ability to work in cross-functional teams is critical for this r

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 client’s goals
Maintain Data Integrity Assessments with the current client and Industry standards
Collaborate with client’s 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)

Basic Qualifications:
Doctorate degree Or
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

Preferred 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 IS department.
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 Must Have Skills:

Strong Automation Engineer experience - specifically experience in Drug Product Automation preferable.
Experience in developing and maintaining process control automation solutions.
Experience in leading/ supporting technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.

Interview process:
Virtual interviews via Webex.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.