New job Manager- Sterilization in Maharashtra
Company : Johnson & Johnson Family of Companies
Salary : Details not provided
Location : Maharashtra
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We adopt 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 creativity to deeply change the trajectory of health for humanity.
Johnson & Johnson is the world’s most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world contend in consumer, pharmaceutical and medical devices markets and have the skills and resources to tackle the world’s most pressing health issues.
SECTION 1: JOB SUMMARY*
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.
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.
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 standards.
- 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
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 based on 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.
EXPERIENCE AND EDUCATION*
Master’s Degree in Engineering/ M.Pharma/Msc Microbiology from reputed college with minimum 6 years of experience or Bachelor’s degree in Engineering with minimum 10 years of experience.
Prior experience in sterilization / Aseptic manufacturing required.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
- Demonstrates knowledge of technical principles of processes and technologies (i.e. mechanical, electrical, software, )
- 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.
- Demonstrates good analytical and problem-solving skills, technology and data management as well as sound decision making
- 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.
Johnson & Johnson Private Limited (8080)