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Biomedical Engineer - Thousand Oaks, United States - EPITEC
Description
100% ONSITE - Thousand Oaks, CA. Possibly visiting vendor sites within the US (once a quarter possibly for a week)
Our client is looking for Engineers to support Clinical & Commercial Plant Automation programs and Capital projects, including complex and challenging automation initiatives that require a solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, product lifecycle management, and operational excellence. They will require an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.
Job Responsibilities:
Represent ATA 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 using Manufacturing Information and Technology System (MITS).
* Represent ATA Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with Engineering and GCPM.
Represent ATA 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 ATA 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 CMDB systems.
* Ensure compliance to Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
Represent ATA 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 ATA Plant Automation team and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
* Manage day-to-day support of ATO Drug substance operations
* Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.
* Available for up to 10% domestic/international travel.
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 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.
