Address Design, execution and documentation of process characterization, process development, equipment qualification, validations, Validation Master Plan, and test methods used in manufacturing processes in the context of the applicable standards and regulations.
Asst. Manager, Process Engineering is responsible to execute Process Engineering deliverables as per the engineering and base business strategies and objectives at the Aurangabad site. He ensures flawless execution of Manufacturing process validations or qualifications. He provides leadership to the Process team and ensures the support from all engineering functions and also other required cross functions. He is responsible to ensure the integration with the regional and WW Process Engineering organization.
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 Validation activities are governed in accordance to Project deliverables.
• 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
CONFIDENTIAL use pursuant to Company Procedures Page 2 of 7
• 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.Bachelor's degree with minimum 8 to 10 years of experience in Engineering/Industrial/Electrical/Mechanical/Chemical Engineering (or related stream).
• Experience in the Medical Device industry or pharmaceutical or consumer or similar industry.
• 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.
• Ability to lead & mentor validation team.
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 preferably, Statistical Data Analysis & process controls, understandings on process capabilities cpk ppk.
• 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.
CONFIDENTIAL use pursuant to Company Procedures Page 3 of 7
• 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.
