Johnson & Johnson companies are equal opportunity employers.
STAFF ELECTRICAL ENGINEER-7716140402
Description
Advanced Sterilization Products, a member of Johnson and Johnson's Family of Companies, is recruiting for a Staff Engineer - Electrical, to support the sterilizer equipment & consumable manufacturing in the Irvine, CA facility.
Advanced Sterilization Productions (ASP), a Johnson & Johnson company, has a long track record of designing and delivering innovative infection prevention solutions that dramatically raise the level of healthcare and safety for those who matter most. Our pioneering technology, global distribution, and established leadership position enable us to simplify the process of buying and operating infection prevention products and services every day, for thousands of medical facilities around the world.
The Staff Manufacturing Electrical Engineer will be responsible for supporting equipment & consumable manufacturing located at the Irvine Site. The individual will coordinate and lead electrical manufacturing projects as assigned to meet all performance requirements including cost, quality, safety and environmental criteria. Responsibilities to include support for all electrical and electronic based manufacturing processes, modifications and upgrades to existing equipment, design and selection of component modifications, preparation of estimates, generation of capital funding, control of project budgets, timely execution of installations, equipment commissioning and validation, development and periodic review of standard operating procedures and specifications, testing procedures and specifications, documentation revision control, non-conformance reports, failure investigations, change orders, corrective action/preventive action documentation, and manufacturing project scheduling and coordination.
The individual will work in direct support of the Irvine Plant operating units and designated project teams to support manufacturing. The Individual will also provide the manufacturing team direct support in routine problem solving of a moderate to complex nature and provide subject matter expertise in identifying and correcting issues. cGMP responsibilities will be directly associated with quality system requirements of owning and managing quality events related to process and facility equipment corrective and preventive actions. There are occasional interactions with FDA and other regulatory agencies.
Qualifications
A BS degree in Electrical Engineering or related discipline is required.
A minimum of 8 years of progressive experience in the pharmaceutical manufacturing, medical device manufacturing or other FDA regulated industry is required.
Previous experience in engineering, operations or related background is required.
Demonstrated ability to quantify, document, and evaluate functional requirements for production and facility systems is required.
Demonstrated skills in developing, writing, and executing cGMP based process and equipment validations is preferred.
Candidates are required to have experience and working knowledge in the one or more of the following areas: PLC programming, HMI design and programming, vision systems, servo systems and automated packaging and assembly equipment, electronic component troubleshooting and manufacturing.
Demonstrated written and verbal communications skills are required.
The ability to communicate technical objectives and content to a varied audience is required.
Previous project management is required.
Six sigma, lean, or black belt training is preferred.
Tech transfer is preferred.
Thorough knowledge of FDA and other regulatory guidance is required.
Proficiency in Microsoft MS Office is required; experience using MS Project and Auto CAD is preferred.
This position will require 10% travel and will be based in Irvine, CA.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
Job Function: Engineering (Generalist)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
STAFF ELECTRICAL ENGINEER-7716140402
Description
Advanced Sterilization Products, a member of Johnson and Johnson's Family of Companies, is recruiting for a Staff Engineer - Electrical, to support the sterilizer equipment & consumable manufacturing in the Irvine, CA facility.
Advanced Sterilization Productions (ASP), a Johnson & Johnson company, has a long track record of designing and delivering innovative infection prevention solutions that dramatically raise the level of healthcare and safety for those who matter most. Our pioneering technology, global distribution, and established leadership position enable us to simplify the process of buying and operating infection prevention products and services every day, for thousands of medical facilities around the world.
The Staff Manufacturing Electrical Engineer will be responsible for supporting equipment & consumable manufacturing located at the Irvine Site. The individual will coordinate and lead electrical manufacturing projects as assigned to meet all performance requirements including cost, quality, safety and environmental criteria. Responsibilities to include support for all electrical and electronic based manufacturing processes, modifications and upgrades to existing equipment, design and selection of component modifications, preparation of estimates, generation of capital funding, control of project budgets, timely execution of installations, equipment commissioning and validation, development and periodic review of standard operating procedures and specifications, testing procedures and specifications, documentation revision control, non-conformance reports, failure investigations, change orders, corrective action/preventive action documentation, and manufacturing project scheduling and coordination.
The individual will work in direct support of the Irvine Plant operating units and designated project teams to support manufacturing. The Individual will also provide the manufacturing team direct support in routine problem solving of a moderate to complex nature and provide subject matter expertise in identifying and correcting issues. cGMP responsibilities will be directly associated with quality system requirements of owning and managing quality events related to process and facility equipment corrective and preventive actions. There are occasional interactions with FDA and other regulatory agencies.
Qualifications
A BS degree in Electrical Engineering or related discipline is required.
A minimum of 8 years of progressive experience in the pharmaceutical manufacturing, medical device manufacturing or other FDA regulated industry is required.
Previous experience in engineering, operations or related background is required.
Demonstrated ability to quantify, document, and evaluate functional requirements for production and facility systems is required.
Demonstrated skills in developing, writing, and executing cGMP based process and equipment validations is preferred.
Candidates are required to have experience and working knowledge in the one or more of the following areas: PLC programming, HMI design and programming, vision systems, servo systems and automated packaging and assembly equipment, electronic component troubleshooting and manufacturing.
Demonstrated written and verbal communications skills are required.
The ability to communicate technical objectives and content to a varied audience is required.
Previous project management is required.
Six sigma, lean, or black belt training is preferred.
Tech transfer is preferred.
Thorough knowledge of FDA and other regulatory guidance is required.
Proficiency in Microsoft MS Office is required; experience using MS Project and Auto CAD is preferred.
This position will require 10% travel and will be based in Irvine, CA.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
Job Function: Engineering (Generalist)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement