Senior Engineer, Controls and Automation - Integra LifeSciences
Plainsboro, NJ
About the Job
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
This position is responsible for supporting the design and development of manufacturing equipment and processes and updating systems for new and existing products.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Support automation projects and automation vendors to deliver new systems, change existing systems, or retire existing systems to support business objectives.
+ Lead development of specifications for equipment control systems for new projects.
+ Lead development of specifications for building management systems for new manufacturing areas.
+ Review documentation for accuracy and relevance as it pertains to system controls.
+ Support Maintenace Department in keeping current automation and control systems updated.
+ Collaborate with Corporate IT in support of projects requiring interfacing.
+ Support network maintenance and projects owned by GAC/IT. Communicate and coordinate all network or system interruptions with system users.
+ Support the computer system validation (CSV) activities for all cGMP automation equipment, including development of documentation as per the ISPE GAMP5 guidelines.
+ Follow standard operating procedures (SOPs) related to equipment, systems, and documentation as required.
+ Complete all assigned tasks following cGMPs, OSHA, EPA, and other Federal and State regulations.
+ Contribute to changes of all automation Standard Operating Procedures (SOP)s and system drawings.
+ Perform system administrator functions for some systems, including managing system users.
+ Perform annual system review for all automation systems.
+ Provide technical support during Non-Conformance (NC’s) and Corrective Action Preventive Actions (CAPA) investigations.
+ Perform automation code updates associated with projects.
+ Maintain system inventory information and backups of all validated software.
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required.
+ Bachelor’s degree in science/engineering, preferably Electrical or Computer with 4-6 years work experience. Other Degree with 8-10 years of experience in related technical field supporting automation/control or computer systems in a GMP production facility.MS Degree with 2-4 years of experience.
+ Ability to take direction and work in a fast-paced environment, communicating and raising questions as needed.
+ Understanding of electricity, electrical circuits, analog and digital input/output devices.
+ Knowledge of electrical diagrams and piping and instrumentation diagrams (P&IDs).
+ Knowledge of Allen Bradley/Rockwell programing software (RSLogix, RSLinks, FactoryTalk, and ControlLogix) preferred.
+ Knowledge of computer networks, including switches, and firewalls.
+ Understanding of cGMP, cGDP, and computer system Validation (CSV)
+ Working knowledge of ISPE GAMP5 guidelines
+ Working knowledge of Lock out Tag out (LOTO) procedures and electrical safety.
+ A record of safe operations and working knowledge of safety standards for plant environments.
+ Knowledge of Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA).
+ Strong writing and communication skills.
+ Experience with personal computers (Windows) and software like MS Project, Word, Excel, and Power Point.
+ Must be available during scheduled shutdowns, in emergency situations, and / or work flexible hours.
+ Available to travel on a minimal basis for training or other purposes.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
This position is responsible for supporting the design and development of manufacturing equipment and processes and updating systems for new and existing products.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Support automation projects and automation vendors to deliver new systems, change existing systems, or retire existing systems to support business objectives.
+ Lead development of specifications for equipment control systems for new projects.
+ Lead development of specifications for building management systems for new manufacturing areas.
+ Review documentation for accuracy and relevance as it pertains to system controls.
+ Support Maintenace Department in keeping current automation and control systems updated.
+ Collaborate with Corporate IT in support of projects requiring interfacing.
+ Support network maintenance and projects owned by GAC/IT. Communicate and coordinate all network or system interruptions with system users.
+ Support the computer system validation (CSV) activities for all cGMP automation equipment, including development of documentation as per the ISPE GAMP5 guidelines.
+ Follow standard operating procedures (SOPs) related to equipment, systems, and documentation as required.
+ Complete all assigned tasks following cGMPs, OSHA, EPA, and other Federal and State regulations.
+ Contribute to changes of all automation Standard Operating Procedures (SOP)s and system drawings.
+ Perform system administrator functions for some systems, including managing system users.
+ Perform annual system review for all automation systems.
+ Provide technical support during Non-Conformance (NC’s) and Corrective Action Preventive Actions (CAPA) investigations.
+ Perform automation code updates associated with projects.
+ Maintain system inventory information and backups of all validated software.
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required.
+ Bachelor’s degree in science/engineering, preferably Electrical or Computer with 4-6 years work experience. Other Degree with 8-10 years of experience in related technical field supporting automation/control or computer systems in a GMP production facility.MS Degree with 2-4 years of experience.
+ Ability to take direction and work in a fast-paced environment, communicating and raising questions as needed.
+ Understanding of electricity, electrical circuits, analog and digital input/output devices.
+ Knowledge of electrical diagrams and piping and instrumentation diagrams (P&IDs).
+ Knowledge of Allen Bradley/Rockwell programing software (RSLogix, RSLinks, FactoryTalk, and ControlLogix) preferred.
+ Knowledge of computer networks, including switches, and firewalls.
+ Understanding of cGMP, cGDP, and computer system Validation (CSV)
+ Working knowledge of ISPE GAMP5 guidelines
+ Working knowledge of Lock out Tag out (LOTO) procedures and electrical safety.
+ A record of safe operations and working knowledge of safety standards for plant environments.
+ Knowledge of Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA).
+ Strong writing and communication skills.
+ Experience with personal computers (Windows) and software like MS Project, Word, Excel, and Power Point.
+ Must be available during scheduled shutdowns, in emergency situations, and / or work flexible hours.
+ Available to travel on a minimal basis for training or other purposes.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences