Process Engineer

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. SECTION 1: JOB SUMMARY* Executing validation activities and required documentation of Manufacturing validation processes including process characterization, process development, equipment qualification/validation, Validation Master Plan and test methods in context of the applicable standards and regulations. SECTION 2: DUTIES & RESPONSIBILITIES* Under supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines: Coordinating and executing the recurring validation activities according to validation master plan. Drafting documents & getting approvals for process characterization, process maps & Equipment Qualification/Validation related activities in projects. Creating validation strategies, test plans, validation specifications, protocols and reports. Documenting changes of methods, processes and material in ADAPTIV (MVI). Supporting the Equipment Qualification & Validation. Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities. Training of employees in validation specifications, test plans, test methods, etc. Supporting the root cause identification and implementation/documentation of any challenges faced during validation and performing corrective measures. Ensuring compliance to the JNJ 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 all activities performed/executed are in a safe manner and as per GMP requirements. Analyzing data statistically and as per specification requirements to evaluate validation/process results. Supporting for Non-Conformance investigations, its trend analysis and preparing required documentation. Ensuring validation activities are executed post training & as per compliance/procedural requirements at Site. Participating in audits and gap assessments to support the internal and any external audit program. Partnering with operations & required stakeholders for validation executions, investigation, corrections, conclusions in order to meet the Project/ Validation deliverables. Adhering to Safety & Credo while working/executing activities. Compliance & Training: Observes & adheres all regulatory/procedural requirements as defined per applicable regulations, rules & procedures established by the Company and notify 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. Qualifications SECTION 3: EXPERIENCE AND EDUCATION* EDUCATION/EXPERIENCE Education: Bachelor’s degree in mechanical / Electrical / Electronics / Instrumentation engineering Experience: 08-10 year’s related experience from Pharmaceutical/Medical device/Engineering industry. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* COMPETENCIES (Technical Skills / Behavioral Skills) The individual should possess knowledge pertaining to – Engineering Basics: Ability to use knowledge of technical designs, Understanding and creating Engineering drawings. 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 identifying improvement opportunities. Understand product requirements and translating into product characteristics and procedures. Ability to define, measure, improve product characteristics and their co-relationship with product performance. Process Excellence: Displays in-depth understanding of Lean tools & techniques, Value stream mapping, Six Sigma, Statistical Data Analysis & process controls. Technical Quality and Compliance: Displays in-depth knowledge of J&J quality standards to implement cross-functional 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. Mechanical Equipment & Systems: Displays in-depth knowledge of commissioning of mechanical equipment, Safety equipment and leverages best practices. Process Validations: Ability to execute qualification strategy for overall process, execution of strategy and plans in a diligent manner; ability to react/resolve issues that occur during qualifications; basic knowledge of statistical techniques. Packaging Equipment and Operation: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Automation & Robotics, Vacuum Technology, Programmable Logic Controllers (PLC), Mechanical Engineering, Sterilization/Cleanroom Technology. Packaging Process: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Packaging Process, Packaging Materials, Test Methods, Packaging Classification & Types. Professional Competencies 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 Skills required Technical Writing & English-speaking skills. Capability for Problem Solving & Analysis of data statistically. Teamwork / Collaboration. Knowledge of local FDA, GMP, EHS & S and other statutory & regulatory standards applicable in manufacturing environment. Knowledge of continuous improvement tools, Lean Manufacturing & Six- Sigma. Knowledge of SAP, Visio, MS Projects, Minitab, ADAPTIV, ETQ Audit, ETQ CAPA, ETQ NC & Compliance Wire. 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 2206058894W