Assistant Manager Sterilization

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

Job Function

Supply Chain Engineering

Job Sub Function

Manufacturing Engineering

Job Category

Scientific/Technology

All Job Posting Locations:

Aurangabad, Maharashtra, India

Job Description

SECTION 1: JOB SUMMARY*

• Design, execution and documentation of process characterization, process development, equipment qualification, validations, Manufacturing Equipment and Sterilization Validation Master Plan, and test methods used in manufacturing processes in the context of the applicable standards and regulations.
• Lead- Process Engineering is responsible to execute process engineering deliverables as per the engineering and base business strategies and objectives at the Aurangabad site. Ensures flawless execution of Manufacturing process validations or qualifications. Provides leadership to the Process team and ensures the support from all engineering functions and also other required cross functions. Responsible to ensure the integration with the regional and WW process engineering organization.
• 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 and regular maintenance. 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.
• Is responsible for the Process Safety Management activities for the site.
  
  

SECTION 2: DUTIES & RESPONSIBILITIES*

• Ensures coordination and execution of the recurring validation activities according to validation master plan.
• Leads cross functional teams (internal and external to engineering) and resolves inter- functional issues.
• Establishes and communicates process and program schedules, objectives, priorities, and targets.
• Ensures the documentation of project and program activities and deliverables.
• 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 a 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 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.
• Ensuring for training / compliance of GMP as per FDA guidelines and site procedures and Policies and on the job training.
• Participating in audits and gap assessments in support of the internal audit program and FDA readiness.
• Partnering with operations in the investigation / correction of process failure
• Developing safety culture in the engineering function.
• 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.
  
  

AUTHORITIES

• Create PR in emp/Ariba.
• Create & Approve PR in emp/Ariba
• Create/Approve Gate Pass for material.
• Change Assessment creation in ADAPTIV/ PLM system.
• CO/CP creation in ADAPTIV/PLM system.
• QMS document Approval creation/Approval in ADAPTIV/ PLM system.
  
  

SECTION 3: EXPERIENCE AND EDUCATION*

• Bachelor’s degree with minimum 10 to 12 years of experience in Engineering/Industrial/Electrical/Mechanical Engineering (related stream).
• Experience in the Medical Device industry or pharmaceutical or consumer or similar industry with experience in aseptic handling.
• Demonstrated knowledge of manufacturing principles and practices and procedures.
• Knowledge of specific business practices and software and software applications.
• Experience using medical device equipment.
• Ability to communicate effectively with a diverse client/stakeholder base.
• Ability to work cooperatively with coworkers, peers and required stakeholders.
• Ability to perform duties in accordance with policies and procedures.
  
  

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

Functional Competencies -

• 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 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.
• Image/Signal Processing and Robotics: Displays in-depth Knowledge within image analysis, image processing, image algorithms, robotic systems, software and verification systems development and leverages the skills and leading Practices to implement processing strategy.
• Mechanical Equipment & Systems: Displays in-depth knowledge of commissioning of mechanical equipment, Safety equipment and leverages best practices.
• Process Validations: Ability to develop/plan 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.
• Packaging Design: Displays in-depth Knowledge within Develops & Implements New Technology concepts and methods and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities.
  
  

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.
• 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.
• Knowledge of project management methodologies (e.g., 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, Minitab, ADAPTIV, ETQ Audit, ETQ CAPA, ETQ NC & Compliance Wire.