Johnson & Johnson Innovative Medicine
CSV Automation Engineer
Johnson & Johnson Innovative Medicine, Wilson, North Carolina, United States, 27893
Overview
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CSV Automation Engineer
role at
Johnson & Johnson Innovative Medicine . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Learn more at https://www.jnj.com. Location: Wilson, North Carolina, United States of America. The CSV Automation Engineer works with the CSV Automation Lead and is responsible for supporting all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. The position will support validation activities, take ownership of development and approval of validation documents for certain systems in the plant. The position will closely collaborate with the automation and QA teams to ensure that accurate impact assessment is determent and site GMP guidelines followed. The CSV Automation Engineer is responsible for developing a process for and performing validation of computer and/or automation systems in compliance with current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11. Key Responsibilities
Review and approve cGMP automation documents including: DeltaV, PAS-X MES and OSI PI software FAT and SAT protocols/reports, software OQs, and Software Installation Verification protocols. Review and approve non-cGMP automation documents including Honeywell BAS software, FAT and SAT protocols/reports. Develop a process for the validation of computer and automation systems ensuring compliance with required regulatory requirements. Coordinate and execute training of required personnel on the computer and automation systems validation procedures and methodology. Keeps systems and processes developed for computer and automation systems validation up to date and compliant. Lead and administer KNEAT folders and documentation for Computer System Validation efforts. Support with development of user requirements specification (URS) to ensure requirements are testable and meet 21 CFR Part 11. Support with development of CSV documentation for automation systems such as risk & impact assessment, computer system validation plans, traceability matrix lease reports, and all documents within the scope of the Automation Master Validation Plan as needed. Ensure that the Computer System Validation on the project is conducted to a consistently high standard, following JNJ and GMP guidelines. Support C&Q team during commissioning on various CSV topics. Drive regular communication with QA & Automation team to ensure all GMP guidelines are followed and implemented. Perform Data Integrity for the computer and/or automation systems. Provide recommendations for the control of system’s data assuring its integrity. Keep the inventory list of the computerized and/or automation system. Provide guidance on all activities related to computer and automation systems validation. Support activities include, but are not limited to, SOP creation, documentation review and approval. Qualifications
Education: A Bachelor’s degree in Computer Science, Automation, Electrical Engineering, or a closely related field; is required. Experience And Skills Required: A minimum 2 years of related experience. A minimum 1-year experience in Computer System Validation in a cGMP pharmaceutical facility in compliance with FDA regulations. Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex 11. Good communication & organizational skills when working within multi-functional teams, demonstration task ownership. Knowledge of the SDLC. Support internal and regulatory audits regarding CSV. Preferred: Experience working with Werum PAS-X MES. Knowledge of electronic protocol execution systems like Kneat. 1 year’s experience in generating change controls. Knowledge and understanding in Siemens PLCs and related Computer System Validation efforts. Excellent interpersonal skills and ability to work in a team-based environment with employees at all levels. Leadership skills and the ability to work in multi-functional team environments, as well as independently, and to lead multiple and challenging projects. Other Ability to travel up to 10% of the time, domestic and internationally. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Join to apply for the
CSV Automation Engineer
role at
Johnson & Johnson Innovative Medicine . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Learn more at https://www.jnj.com. Location: Wilson, North Carolina, United States of America. The CSV Automation Engineer works with the CSV Automation Lead and is responsible for supporting all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. The position will support validation activities, take ownership of development and approval of validation documents for certain systems in the plant. The position will closely collaborate with the automation and QA teams to ensure that accurate impact assessment is determent and site GMP guidelines followed. The CSV Automation Engineer is responsible for developing a process for and performing validation of computer and/or automation systems in compliance with current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11. Key Responsibilities
Review and approve cGMP automation documents including: DeltaV, PAS-X MES and OSI PI software FAT and SAT protocols/reports, software OQs, and Software Installation Verification protocols. Review and approve non-cGMP automation documents including Honeywell BAS software, FAT and SAT protocols/reports. Develop a process for the validation of computer and automation systems ensuring compliance with required regulatory requirements. Coordinate and execute training of required personnel on the computer and automation systems validation procedures and methodology. Keeps systems and processes developed for computer and automation systems validation up to date and compliant. Lead and administer KNEAT folders and documentation for Computer System Validation efforts. Support with development of user requirements specification (URS) to ensure requirements are testable and meet 21 CFR Part 11. Support with development of CSV documentation for automation systems such as risk & impact assessment, computer system validation plans, traceability matrix lease reports, and all documents within the scope of the Automation Master Validation Plan as needed. Ensure that the Computer System Validation on the project is conducted to a consistently high standard, following JNJ and GMP guidelines. Support C&Q team during commissioning on various CSV topics. Drive regular communication with QA & Automation team to ensure all GMP guidelines are followed and implemented. Perform Data Integrity for the computer and/or automation systems. Provide recommendations for the control of system’s data assuring its integrity. Keep the inventory list of the computerized and/or automation system. Provide guidance on all activities related to computer and automation systems validation. Support activities include, but are not limited to, SOP creation, documentation review and approval. Qualifications
Education: A Bachelor’s degree in Computer Science, Automation, Electrical Engineering, or a closely related field; is required. Experience And Skills Required: A minimum 2 years of related experience. A minimum 1-year experience in Computer System Validation in a cGMP pharmaceutical facility in compliance with FDA regulations. Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex 11. Good communication & organizational skills when working within multi-functional teams, demonstration task ownership. Knowledge of the SDLC. Support internal and regulatory audits regarding CSV. Preferred: Experience working with Werum PAS-X MES. Knowledge of electronic protocol execution systems like Kneat. 1 year’s experience in generating change controls. Knowledge and understanding in Siemens PLCs and related Computer System Validation efforts. Excellent interpersonal skills and ability to work in a team-based environment with employees at all levels. Leadership skills and the ability to work in multi-functional team environments, as well as independently, and to lead multiple and challenging projects. Other Ability to travel up to 10% of the time, domestic and internationally. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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