GMP - (JP13780)

3 Key Consulting•Thousand Oaks, CA

7d•Onsite

About The Position

We are seeking a professional Principal Automation Engineer for a long-term contracting opportunity with our client, a global leader in the biotech industry, as a member of the Manufacturing & Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team. The successful candidate will be required to support Clinical & Commercial Plant Automation Programs and Capital Projects for the EPO Manufacturing team, including complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and operational excellence. This position requires an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies. This role is expected to deliver on assigned capital projects and drive accountability.

Requirements

Life science experience
Rockwell Automation Experience
GMP Manufacturing facility experience
Doctorate degree and 2 years of experience or Master degree and 6 years of experience or Bachelor degree and 8 years of experience.

Nice To Haves

Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product and Supply chain plant operations.
Has five or more years combined experience with the following automation systems: Emerson Delta-V DCS system. Rockwell Automation SCADA and PLC Platform. ABB Robot and Mitsubishi roller bottle machine Emerson Delta-V DCS system. Electronic Batch Reporting Systems Design and implementation experience.
Process Control Network design including network segregation.
Process Control Systems: Virtual Infrastructure design and implementation.
System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.
Proficient in project management skills.
Ability to influence and motivate others outside of direct line of authority.
Strong ability to interface effectively with all levels.
Effective meeting management.
Quick learner; proactive; takes initiative.
Results oriented and goal driven.
Ability to organize, interpret, communicate, and/or present information.
Proficient facilitation, negotiation, problem-solving, and conflict resolution skills.
Strong oral and written communication skills.
Demonstrates willingness to put in extra effort when necessary to pursue tasks and conclusion.

Responsibilities

Manage day-to-day support of ATO Drug substance operations
Represent plant automation team in Area WCTs
Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects.
Lead the direct reports including External Workers (EWs), onboarding the EWs, and ensuring the direct reports’ adherence to client training requirements.
Represent Plant Automation team during the development of project plan, business case, and cost estimates in partnership with key customers and stakeholders – ATO MCS Plant Operations, Engineering, Operations Information Systems (OIS), Global Construction Project Management (GCPM), and provide necessary support to obtain funding approval.
Based on project scope, work with OIS to estimate manhours and required resources
Represent Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with Engineering and GCPM.
Represent Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
Represent Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and Client CMDB systems.
Ensure compliance to Client Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
Represent Plant Automation team and support functional area projects focused on improving process equipment/utilities/facilities -to- large/sophisticated capital projects to integrate new drug substance and drug product manufacturing technologies into clinical/commercial facility.
As applicable to the capital project scope, represent Plant Automation team and support new continuous improvements by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.