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Johnson & Johnson Family of Companies Hiring for Process Engineer at Aurangābād Full Time
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Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science – bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to reimagine the way healthcare is delivered and help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, vision and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions.
As pioneers in medical devices, we continually focus on elevating the standard of care—working to expand patient access, improve outcomes, reduce health system costs and drive value. We create smart, people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.
JOB SUMMARY
Design, execution and documentation of process characterization, process development, equipment qualification, validations, and test methods used in manufacturing processes in the context of the applicable standards and regulations
DUTIES & RESPONSIBILITIES
- Leading, coordinating and executing the recurring validation activities according to validation master plan Leading of process characterization & development activities in projects and initiatives
- Creating validation strategies, test plans, validation specifications, protocols and reports
- Documenting changes of methods, processes and material in ADAPTIV (MVI)
- Leading the equipment qualification • Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities •
- Training of employees in validation specifications, test plans, test methods, etc.
- Supporting the selection of processes / machines, taking into account the requirements of project and production as well as investment and cost aspects • Ensuring an effective process risk management (FMEA) carrying out process risk analysis process participation in product risk analysis
- Developing manufacturing processes under application / taking into account methodological concepts (Six Sigma, Lean).
- Supporting the root cause identification and implementation/documentation of corrective measures during the stabilization phase of a product / process development project
- Taking over of co-ordination and project management tasks for the Aurangabad site if no project manager is associated with the project
- Ensuring process optimization within the stabilization phase of assigned project • Engages to comply with ISO and FDA requirements • Ensuring compliance to the Quality system requirements.
- Utilizing problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision.
- Assuring that engineering department is appropriately run in a safe, clean and environmentally sound manner.
- Developing and analyzing statistical data and machine specification so as to determine present standards and establish proposed quality and reliability expectancy of finished product
- Assisting in engineering budget preparation, goal tracking and in the business planning process.
- Supporting for NCR’s investigation and performs trend analysis and report to Management
- Partnering with operations in the investigation / correction of process failure
- Developing safety culture in the engineering function
- Responsible for updating the Record retention schedule for Engineering department every year
- Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notified any violation or deviation to the immediate supervisor or appropriate authority.
- Complies with all training requirements to perform duties of the job.
- Ensure adherence/compliance to Records Management policies and procedures, as applicable
- Authorized for approval of Returnable Gate Pass, Invoices
- Authorized for approval as per delegation process
- Responsible for communicating business related issues or opportunities to next management level.
- 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
- As IOSS area owners(if applicable) need to do following activities
- Overall responsibility to implement all expectations as communicated by chapter owners
- Ensure role and responsibility of individual to comply with EHSS expectation
- Ensure EHSS meeting, assessments, audits in the area. Ensure people attends EHSS TRAINING as per plan.
- Guide to area members to understand the EHSS expectations and track their Guide performance on implementation.
- Ensure monthly Gemba round in the area and 90% on time closer
Qualifications
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
Functional Competencies:
The individual should possess knowledge pertaining to –
- Engineering Basics: Ability to use knowledge of Technical designs, Understanding and creating Engineering drawings and leads key site projects/base business automation initiatives.
- Manufacturing processes Knowledge: Displays in-depth knowledge of manufacturing methods and standards of process control. Leverages the knowledge and leads practices to implement sustainable process improvements in assigned areas.
- Product knowledge: Understanding of Product functionalities and identifies improvement opportunities. Understand product requirements and translate into product characteristics and procedures. Ability to define, measure, improve product characteristics and their co-relation with product performance.
- Process Excellence: Displays in-depth understanding of Lean tools & techniques, Value stream mapping, Six Sigma as a certified Black Belt, Statistical Data Analysis & process controls.
- Technical Quality and Compliance: Displays in-depth knowledge of J&J quality standards to implement crossfunctional corrective action related to quality issues. Use in-depth knowledge of EHS policies to guide others when implementing EHS initiatives.
- Standard Cost generation: Displays in-depth Knowledge within Financial Systems and Budget Preparation, ROI calculation, standard cost planning and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities.
Professional Competencies:
The individual should possess knowledge pertaining to – •
- Analytical Problem Solving: Applies understanding of analytic techniques to interpret data, identify issues, analyze causes of the issues and provide well-reasoned conclusions and solutions.
- Technology & Data Management: Uses in-depth knowledge of system and technology capabilities, architecture, and leading practices to effectively interface with IT professionals to identify, select, and implement tools that enable business processes.
- Quality Mindset: Participates in quality processes, as appropriate, including validation and compliance-related issues (for example, FDA regulations, holds, customs, etc.) Demonstrates an understanding of the critical importance of traceability and ability to apply supporting approaches or technologies (i.e. lot coding, expiration dating, etc.) Applies knowledge of validation strategies and/or continuous improvement concepts to proactively identify process deficiencies or improvements.
- Analytical Problem solving: Uses in-depth knowledge of analysis and problem-solving techniques to study reports, identify underlying issues or trends, and assess broader implications of the findings, based upon the interpretation of quantifiable data, to recommend appropriate solutions
- Project Management: Demonstrates expertise in project management tools and techniques, interactions with project stakeholders and sponsors. Identifies innovative ways to improve cost or lead-time to maximize resources to achieve project outcomes. Leverages understanding of FPX and other project management methodologies to perform root-cause analysis on project failures.
- Business Case Development: Uses in-depth knowledge of business case development to articulate the business case for broad, cross-departmental change to decision-makers Mentors others by providing direction and context for change by outlining linkages between functional activities and J&J’s bottom line
Are you ready to impact the world?
Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job
Primary Location
India-Maharashtra-Aurangabad-
Organization
Johnson & Johnson Private Limited (8080)
Job Function
Engineering
Requisition ID
2105968860W