CSV Automation Engineer

Job description

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.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com

**Job Function:**

Supply Chain Engineering

**Job Sub** **Function:**

Automation Engineering

**Job Category:**

Scientific/Technology

**All Job Posting Locations:**

Wilson, North Carolina, United States of America

**Job Description:**

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine .

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients.

The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience.

J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

The GET (Global Engineering & Technology) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions.

We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network.

Apply today for this great opportunity located in Wilson, NC!

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 CVS Automation Engineer for Johnson & Johnson Innovative Medicine is responsible for developing a process for and performing of validation of computer and/or automation systems compliance 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.
+ Coordinates and executes 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 administrate 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 system such as risk & impact assessment, computer system validation plans, traceability matrix lease reports, and all documents and work 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 recommendation for the control of system’s data assuring its integrity.
+ Keep the inventory list of the computerized and/or automation system.
+ Gives 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/Annex11
+ 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 years’ experience in generating change controls
+ Knowledge and understanding in Siemens PLCs and related Computer system validation efforts
+ Excellent interpersonal skills and ability to work optimally and efficiently 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.

Required Skill Profession

Other General