Description:
Amgen Job Description:
Global leader in the Biotechnology industry is seeking a professional Principal Automation Engineer for employment. As a member of the Amgen Manufacturing Clinical Supply MCS - Facilities Engineering FE Automation team the successful candidate will be required to support Clinical Commercial Plant Automation Programs and Capital Projects for ATO Manufacturing 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 experience 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.
Job Responsibilities:
1 Manage day-to-day support of ATO Drug substance operations
2 Represent plant automation team in Area WCTs
3 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 Amgen training requirements.
4 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.
5 Based on project scope work with OIS to estimate manhours and required resources
6 Represent Plant Automation team and participate in the preparation and implementation of detailed design scope schedule in partnership with Engineering and GCPM.
7 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.
8 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 Amgen CMDB systems.
9 Ensure compliance to Amgen Engineering and Operational standards specifications and procedures as applicable during the project design and implementation.
10 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.
11 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.
12 Support a safe working environment by complying with all pertinent environmental health/safety practice rules and regulations.
Preferred Qualifications:
1 Degree in Electrical Engineering or Computer Science Chemical Engineering Biotech Engineering or related life science engineering.
2 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.
3 Has five or more years combined experience with the following automation systems:
o Emerson Delta-V DCS system.
o Rockwell Automation SCADA and PLC Platform.
o ABB Robot and Mitsubishi roller bottle machine
o Emerson Delta-V DCS system.
o Electronic Batch Reporting Systems Design and implementation experience.
o Process Control Network design including network segregation.
o Process Control Systems: Virtual Infrastructure design and implementation.
o System Integration using OPC Foundation Fieldbus Profibus and DeviceNet technologies.
o Compliance to regulatory requirements such as 21 CFR Part 11 ASTM 2500 S88 S95 and GAMP.
Preferred Competencies:
1 Proficient in project management skills.
2 Ability to influence and motivate others outside of direct line of authority.
3 Strong ability to interface effectively with all levels.
4 Effective meeting management.
5 Quick learner proactive takes initiative.
6 Results oriented and goal driven.
7 Ability to organize interpret communicate and/or present information.
8 Proficient facilitation negotiation problem-solving and conflict resolution skills.
9 Strong oral and written communication skills.
10 Demonstrates willingness to put in extra effort when necessary to pursue tasks and conclusion.
Skills:
automation, plc programming, programming, controls engineering, rockwell, allen-bradley, gmp, gmp environment, gmp iso, iso 13485, pharmaceutical, medical device, hmi
Top Skills Details:
automation,plc programming,programming,controls engineering,rockwell,allen-bradley,gmp,gmp environment,gmp iso,iso 13485,pharmaceutical,medical device,hmi
Experience Level:
Expert Level
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