Principal Engineering Clerk (Fixed Term)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at Surgery

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery Ready to join a team thats reimagining how we heal Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the worlds most prevalent conditions such as obesity cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at internal pre-identified candidate for consideration has been identified. However all applications will be considered.

We are searching for the best talent for PRINCIPAL ENGINEERING CLERK for Ethicon in Ciudad Juarez.

Purpose:

• Provide overall support for engineering activities.
• Provide support during validation activities and writing the documentation.
• Responsible for engineering purchases through different purchasing platforms
• Provide overall support for VMP activities.

You will be responsible for:

In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• Perform NCR lifecycle documentation and investigation using statistical concepts.
• Provides technical support to identify the causes of non-conformances and process failures and to implement corrections thus assuring process performance and compliance against Ethicons QSR GMP and ISO requirements for the manufacturing process.
• Performs non-conformance investigations including NCR origination bounding product control failure investigation correction and documentation with the non-conformance system.
• Support engineers in performing validation activities execution of protocols engineering studies and documentation.
• Help Write engineering documentation (protocols procedures special instructions reports etc.)
• Supports the documentation changes in compliance with Ethicons Change management system.
• Engineering support in the completion of projects mainly focused on quality improvements cost/scrap reduction increased capacity and New Products.
• Conduct robust investigations. Analyzes data and recommends actions for process equipment and system improvement.
• Review all PLM System (Software solution used by Quality Systems to manage the document control process) validation documentation to Complete VMP Action Tasks.
• Update VMP logs with all applicable validation references protocols completion reports etc. that support the validated state of the validation components.
• Generate and provide quarterly change orders to create release and revise VMP Procedures and VMP Logs.
• Ensure all validation packages (group of a specific document class) involve the required documentation to support and assure the validated state of a validation component.
• Monitoring tracking and assurance that the annual review activities are performed.
• Ensure Validation Baseline/Periodic Reviews are completed on time.
• Supports the VMP related documentation changes in compliance with Ethicons Change management system.
• Responsible for following all Company guidelines related to Health Safety and Environmental practices

• as applicable.

• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
• Performs other duties assigned as needed.

Qualifications / Requirements:

EDUCATION: A minimum of High School Diploma and Engineering Bachelors Degree complete or in progress.

EXPERIENCE: From 6 to 8 years of experience in related fields. Or currently pursuing an Engineering Bachelors Degree with half of School credits completion or recently completed.

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Bilingual English/Spanish (Preferred).
• Computer skills: Excel (including charts/graphs) Word Internet Explorer.
• Experience in medical device manufacturing environment. (Preferred)
• Knowledge of medical product and process design concepts such development materials standardization science and basic statistics. (Preferred)
• Knowledge of word processing spreadsheet analysis presentation graphics some engineering analysis and some statistical software (Minitab preferred).
• Analytical thinking to provide and lead product inquiry investigations.
• Ability to work in a cross-functional team to complete projects knowledge in PE tools such as Kaizen
• Ability to solve basic problems using Fl methodologies such as Five Whys 5Ms and others.
• Self-motivated
• Strong communication and interpersonal skills.
• Requires good networking.
• Entails significant interaction with technical peers and manufacturing associates.
• Self-motivated and capable of completing job duties with limited supervision.

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