Infotree Global Solutions
Principal Automation Engineer (Delta V /Emerson/DCS) at Infotree Global Solution
Infotree Global Solutions, Thousand Oaks, California, United States, 91362
Principal Automation Engineer (Delta V / Emerson / DCS) – Infotree Global Solutions, Thousand Oaks, CA
Description
Principal Automation Engineer (Delta V) The ideal candidate for the Principal Automation Engineer (Delta V) role will have extensive expertise in Delta V batch control systems, with a minimum of 4–5 years of direct, hands‑on Delta V experience specifically in pharmaceutical manufacturing environments. They should demonstrate proficiency in coding, troubleshooting, and addressing complex alarms or system issues in Delta V. Candidates should ideally hold a Bachelor’s degree (Chemical, Electrical, Automation Engineering, Computer Science, Electronics, or similar technical field). However, substantial practical Delta V experience can outweigh formal educational qualifications. A strategic mindset, excellent troubleshooting skills, and strong interpersonal capabilities are crucial, as the role involves frequent collaboration across various teams. Experience in PLC systems and Delta V system administration is beneficial but not mandatory. Candidates must show a track record of stability in their previous employment, with demonstrated capacity for maintaining long‑term roles.
Lead Principal Engineer for Medical Devices Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro‑infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro‑mechanical medical devices. The Principal Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Principal Engineer is to work within a cross‑functional organization to utilize technologies and methodologies that support short‑cycle robust device development.
Responsibilities
Work cross‑functionally with individuals and project teams in Marketing, Operations, and Development
Create and assess product requirements to determine technical coverage and proper integration of different subsystems
Create and execute project plans and schedules
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects
Provide deep technical assistance for junior engineers
Skills
BS in Engineering and previous experience in a medical device industry
10 years current experience with engineering processes and procedures
Led projects from development through the 510(k) and PMA approval process
Strong background in engineering and commercialization of electro‑mechanical medical devices
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA
Product design/development (design control) from concept to post‑product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510(k)) submissions
Experience in drug/device combination product design and development
Familiar with the following standards:
Quality System Regulation (21 CFR 820)
Risk Management (ISO 14971)
EU Medical Device requirements (Council Directive 93/42/EEC)
Medical Electrical Equipment (EN 60601)
Small‑scale device assembly experience
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Strong problem‑solving, risk assessment, and risk management skills
Must be capable of working on multiple projects in a deadline‑driven environment
Very important note: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, or Systems/Software Engineering background need apply and will be considered!!!
Top 3 Must Have Skill Sets
Emerson Delta‑V DCS system with batch control and recipe management
System Integration using OPC, Profibus, EIP, WIOC, and DeviceNet technologies
DeltaV Virtual infrastructure configuration, management, and troubleshooting
Day to Day Responsibilities
Develop and maintain process control automation solutions using DeltaV Distributed Control System (DCS)
Lead or support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations
Lead or support new technology introductions (NTI) and new product introductions (NPI) by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as needed
Identify and implement continuous improvement projects that align with Client initiatives around Safety, Reliability, Efficiency and Environmental sustainability
Maintain automation system health and resiliency via cybersecurity, data integrity, and preventative maintenance in alignment with the latest Client and industry standards
Align and standardize code implementation within the DSS plant network
On‑site production support during normal business hours and on‑call support after hours
Refining or creating business process improvements including departmental Standard Operating Procedures (SOP)
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Principal Automation Engineer (Delta V) The ideal candidate for the Principal Automation Engineer (Delta V) role will have extensive expertise in Delta V batch control systems, with a minimum of 4–5 years of direct, hands‑on Delta V experience specifically in pharmaceutical manufacturing environments. They should demonstrate proficiency in coding, troubleshooting, and addressing complex alarms or system issues in Delta V. Candidates should ideally hold a Bachelor’s degree (Chemical, Electrical, Automation Engineering, Computer Science, Electronics, or similar technical field). However, substantial practical Delta V experience can outweigh formal educational qualifications. A strategic mindset, excellent troubleshooting skills, and strong interpersonal capabilities are crucial, as the role involves frequent collaboration across various teams. Experience in PLC systems and Delta V system administration is beneficial but not mandatory. Candidates must show a track record of stability in their previous employment, with demonstrated capacity for maintaining long‑term roles.
Lead Principal Engineer for Medical Devices Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro‑infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro‑mechanical medical devices. The Principal Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Principal Engineer is to work within a cross‑functional organization to utilize technologies and methodologies that support short‑cycle robust device development.
Responsibilities
Work cross‑functionally with individuals and project teams in Marketing, Operations, and Development
Create and assess product requirements to determine technical coverage and proper integration of different subsystems
Create and execute project plans and schedules
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects
Provide deep technical assistance for junior engineers
Skills
BS in Engineering and previous experience in a medical device industry
10 years current experience with engineering processes and procedures
Led projects from development through the 510(k) and PMA approval process
Strong background in engineering and commercialization of electro‑mechanical medical devices
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA
Product design/development (design control) from concept to post‑product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510(k)) submissions
Experience in drug/device combination product design and development
Familiar with the following standards:
Quality System Regulation (21 CFR 820)
Risk Management (ISO 14971)
EU Medical Device requirements (Council Directive 93/42/EEC)
Medical Electrical Equipment (EN 60601)
Small‑scale device assembly experience
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Strong problem‑solving, risk assessment, and risk management skills
Must be capable of working on multiple projects in a deadline‑driven environment
Very important note: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, or Systems/Software Engineering background need apply and will be considered!!!
Top 3 Must Have Skill Sets
Emerson Delta‑V DCS system with batch control and recipe management
System Integration using OPC, Profibus, EIP, WIOC, and DeviceNet technologies
DeltaV Virtual infrastructure configuration, management, and troubleshooting
Day to Day Responsibilities
Develop and maintain process control automation solutions using DeltaV Distributed Control System (DCS)
Lead or support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations
Lead or support new technology introductions (NTI) and new product introductions (NPI) by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as needed
Identify and implement continuous improvement projects that align with Client initiatives around Safety, Reliability, Efficiency and Environmental sustainability
Maintain automation system health and resiliency via cybersecurity, data integrity, and preventative maintenance in alignment with the latest Client and industry standards
Align and standardize code implementation within the DSS plant network
On‑site production support during normal business hours and on‑call support after hours
Refining or creating business process improvements including departmental Standard Operating Procedures (SOP)
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