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*
Designs, develops, tests, and evaluates new and existing manufacturing systems for industrial production processes including human work factors, material flow, cost analysis, and process optimization in both production and packaging operations which includes but not limited to Technology Roadmap projects.
Is responsible to develop and execute the Sterilization strategies and objectives at ETHICON, Aurangabad site. Provides the leadership & support to engineering function for execution of EO and GAMMA sterilization projects. Provide Technical knowledge to the Manufacturing engineering, Process engineering and Engineering Projects team.
SECTION 2: DUTIES & RESPONSIBILITIES*
Under limited supervision & general direction and in accordance with all applicable federal, state and local laws/ regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Prepares capital expenditure proposals starting from preparation of draft proposals, vendor selection, price
negotiations, planning, and execution. Leads projects end-to-end.
Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no impact to quality or customer service. Develop and execute detailed project plans using standard project management tools (charter, Gantt chart, etc.). Prepare/review capital & expense forecasts for assigned projects. Prepare capital authorization requests (CAR).
Sterilization: Under limited supervision & general direction and in accordance with all applicable federal, state and local laws/ regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Prioritize, assign and coordinate for EO & Gamma sterilization, UDI, serialization and related work.
Establish, review and communicate plans (work/project scope, cost, schedule, resource requirements, and risks) for sterilization related activities required to meet system demands and business objectives.
Lead & prepare a sterilization road map and prepare a strategy to implement them. Support in preparing technology road map and prepare a strategy to implement them.
Lead the various sterilization related projects in tandem with WW sterilization experts.
Lead & deliver projects like sterilizer replacement, new cycle creation, existing cycle improvement (as needed) and new practices development.
Monitor progress to ensure final deliverable meet lifecycle boundaries and customer acceptance criteria.
Engage to comply with ISO and local FDA requirements. Responsible for revision I creation of documents like SOP, Forms etc required for manufacturing /Sterilization/UDI/Serialization & as required.
Ensure and comply with EO & GAMMA Sterilization process requirements.
Ensure to comply the Annual re-certification of Ethylene Oxide sterilization process and GAMMA process is as per ISO 11135 and ISO 11137 requirements.
Accountable for eliminating significant quality issues due to Sterilizer. Ensure compliance to the Quality system requirements. Utilize Problem solving skills and statistical techniques to support product I processes controls that are aligned with the overall quality and business vision.
Signing, writing and approving of protocols, IQ, OQ & PQ documents and validation strategy.
Projects : Report status on assigned projects in formats adequate to different organizational levels.
Ensure machine design complying to J&J safety guidelines including all OSHA and J &J Machine Guarding requirements.
Follow the Ethicon change control process for all applicable projects.
Perform process validations on new, transferred, or modified processes.
Understand the product and process structure (BOMs, Routes, DMR, etc.)
Propose project ideas through analysis of existing processes and equipment with the intent of achieving continuous improvement, including the business case assessment.
Leads project teams effectively with internal and external resources from Quality Engineering, Procurement, Global Supply Chain, Finance, Manufacturing (OPS) and suppliers.
Develops and maintains a network of suppliers and partners.
Perform technical assessments and develop validation strategies and understand the impact on E2E supply chain.
Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no negative impact to quality or customer service.
Manage the NCR and CAPA process by documenting, investigating, root cause analysis, and implementing corrective actions for product non-conformances.
Ensure effective use of engineering and quality systems and adherence to quality system regulations (QSR).
Ensure compliance to the quality policy in all activities.
Support and promote the safety and industrial hygiene objective of the plant
Actively supports the plant vision and technology strategy and provide coaching to engineers & technicians.
Actively looks for collaboration, benchmarks best practices within MD&D network and beyond as well as competitor activities.
Applies the standards of the J&J related Change Management principles.
Applies LEAN and Six Sigma principles
Partners with operations in the investigation / correction of process failure.
Participate in audits to support of internal audit and external audit programs.
Partner with operations for investigation/correction of process failure.
Review & Approve QMS (Quality System Documents).
Provide technical guidance to all departments related to product and process knowledge.
Stabilization of New technology/Equipment and handing over to Process Owner.
Partner closely with different key manufacturing functions supervisors (Production, Maintenance, Engineering, EHS&S, Quality Assurance, NPI, Planning, Finance Procurement).
Connect with Ethicon Global Engineering Platform leads/ Maintenance/Supply Chain Communities to use confirmed solutions or available standar
GENERAL RESPONSIBILITIES:
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
Qualifications
EXPERIENCE AND EDUCATION*
Master’s Degree in Engineering with minimum 6 years of experience or Bachelor’s degree in Engineering with minimum 10 years of experience.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
5.1 Functional Competencies-
Demonstrates good knowledge of manufacturing processes, engineering drawings and re-engineering principles
Understands engineering methods and standards for controlling process i.e. temperature, time, pressure, flows, etc. Understands the process equipment and in-process control instruments.
Knowledge of product design, characteristics, the procedure (how the product works, anatomy), and competitive products
Knowledge of performance requirements of specific products or raw materials and the customer needs
Understands measured product characteristics and their correlation with product/raw material performance.
Knowledge of product applications and surgical techniques. Understanding of market, customers, relevant competitors, and clinical environment.
Lean tools application: The knowledge and ability to apply selected lean tools to a situation. Tools include- 5S, Visual Management, Mistake proofing, Kanban / rhythm wheels and other Lean principles
Knowledge of Six Sigma tools for process improvements
Statistical Data Analysis: Utilizes analytical approach to evaluate product/process data
Demonstrates good knowledge of Quality and Compliance.
Knowledge of Financial systems, ROI Analysis, Standard costs and planning values
Demonstrates sound knowledge of cycle time modelling covering critical path, capacity modeling, time and motion studies
Good knowledge of vacuum technology, PLC programming, electrical and mechanical engineering packaging process and package design.
5.2 Professional Competencies-
Has a quality mindset with a compliance orientation and environmental health & safety commitment.
Has strong business fundamentals covering financial management and budgeting, project management, business case development and business orientation.
Business partnering including Influencing, Change Management and Global Mindset.
5.3 Leadership Behavior Competencies –
Connect: Cultivate external relationships and partnerships. Be insight-driven to uncover unmet needs. Forge internal collaboration across all levels of the enterprise
Shape: Translate insights into viable products and solutions that create value. Challenge the status-quo; lead and adapt to change. Take and manage risks.
Grow: Develops self and others to reach their goals. Engages in open and honest conversations. Drives performance by managing energy and taking ownership for outcomes.
Knowledge of ISO 9001:2008, ISO-13485:2003, ISO-14001 requirements.
Knowledge of local FDA, GMP, EHS & S and other statutory & regulatory standards applicable in manufacturing environment.
Knowledge of project management methodologies (e.g. FPX, PMP etc.)
Knowledge of continuous improvement tools, Lean Manufacturing & Six- Sigma.
Ability to lead a team of professionals with diverse skills and competencies spanning business & technical areas.
Knowledge of SAP based MRP, Visio, MS Project, 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
2105993655W
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