Continuously improves the performance of existing manufacturing processes and equipment through a structured approach. Essential Functions Accountable for: Coordinating production improvements implementation Creating troubleshooting guidelines and/or applicable SOPs and equipment maintenance and repair Identifying possible causes of variation/ failure/ under performance for Manufacturing. Document diagnostics, solution method and impact in troubleshooting for Manufacturing. Measuring Process KPIs for improvement Analyzing through a structured approach to identify root causes. Improving Process KPIs performance Developing control mechanism to ensure Process KPIs consistency. Designing and Coordinating Engineering Tests/ Q's Executing Engineering Tests/ Q's Documenting and Reporting Results of Engineering Tests/ Q's Assuring Readiness of Manufacturing Requirements for the Product Transfer Receiving and Implementing Product and Equipment Transfer Observing, Analyzing, Documenting & Recommending the Start-up of Product Transfer Assuring Operator and BU's resources have the Skills and knowledge coming from change due to Optimizations. Implementation of Optimization Efforts Defining Manufacturing equipment maintenance requirements Developing TPM/ PM/ PDM procedures for Manufacturing Equipment Verifying TPM/ PM/ PDM tasks effectiveness in Manufacturing. Ensuring correct resources are acting upon situation for Equipment Repair Correcting troubles in Manufacturing under performance situation using troubleshooting guidelines and/or applicable SOPs Measuring Equipment Efficiency Identifying Opportunities for Improvements in Equipment Performance Implementing Equipment Upgrades and Optimization Changes Writing Validation Documentation and Test Protocols Documenting all Equipment Changes Assuring Compliance with Laws & Regulations Generation of Purchases Requisition Submitting Scope and Approve Projects Submitting Documentation for Safety Compliance, New Equipment Calibrations, Calibration extensions and Preventive Maintenance Systems & Equipment PM's SOP's Revisions/ Improvements Evaluating Needs for Infrastructure Projects and Start-ups Submitting MSDS as Required Assist in: Supply Chain Performance Indicators Improvement Unit RM Usage Optimization Unit MRO, Incl. Spare Parts Usage Optimization Quarterly Capex meeting with Projects and Owners Team Defining Tactics for Quality First Pass, DPM & CPM Metric (Once a Year) Quality Documentation Approval Quality Awareness Identifying and Implementing Corrective/ Preventive Actions Preparing Rework Protocols or memos for NCRs Investigating NCR, Quality Feedback and Complaint Developing Actions to improve Quality KPI's Developing Procedures for QI Providing Training for QI Providing Support for the QI Start-up Defining and Prioritizing Process KPIs for improvement Writing validation documentation (protocols) Protocol Approval Developing process and regulatory documentation for automation systems Performing and documenting engineering studies Early Involvement in Transference Effort with Technical Innovations (ROI) Assuring Operator and BU's resources have the Skills and knowledge to receive the Product Transfer Early Involvement in LS /Optimization Efforts with Technical Innovations (ROI) Assuring Readiness of Manufacturing Requirements for the Optimization Efforts Identifying possible causes of variation/ failure/ under equipment performance for Manufacturing. Procedure Approval for skills certifications Technical Academy design and delivery Optimizing Unit Performance Shutdown Planning and Execution Active Participation: Inserts Inventory Supplies Unit MRO, Incl. Spare Parts Price Optimization Awareness Unit MRO, Including Spare Parts Inventory Optimization Plant RM & MRO Leverage Opportunities Unit Capacity Utilization $'s Cost Modeling for Process Improvement Material Quality issues avoidance Monitoring Supplier's Performance Evaluating Quality Issues Reports at Manufacturing. & QA Final Investigation (Data gathering of Quality issue) Evaluating NCR Actions Effectiveness Initiating Non-Conformance Resolution Evaluating NCR Leading Improvement Activities Developing supporting Documentation for QI Implementing Safety corrective actions Safety Non-Conformance Resolution Identifying process and/or Manufacturing equipment not performing as expected Ensuring correct resources are acting upon situation for Manufacturing. Designing and programming of Process automation improvement systems Providing technical solutions that increase utilization and reduce costs. Improving accuracy Automation System requirements and specifications for the development of SCADA and other systems Reviewing/ Modifying Standard Operating Procedures for Engineering Controls Final selection of resources Test Design for skills Certifications Preparing Training Module for skills certifications Budget Development and Administration Monitoring Unit Performance People Development Providing Capabilities to Work Unit Qualifications Knowledge, Skills, and Abilities: Knowledge of FDA current GMP/QSR regulation Excellent oral and written communication skills in both English and Spanish languages Teamwork and service oriented Effective leadership Computer literate (PowerPoint, Word, Excel) Willing to Travel Excellent interpersonal skills Highly Motivated, self-starter and responsible person Work Environment: Generally, works in a closed environment, in office conditions, with moderate level of noise and controllable changes of temperature. Needs to stand, walk, and may be seated for a long period of time. Uses hands to feel, handle and reach. Works with a personal computer and programs to prepare documents or reports. Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others. Needs to have high analytical capacity and level of professionalism and judgment to resolve problems. May be exposed to fumes, gases, or strong odors (non-toxic) Experience: Six to ten years of experience with similar responsibilities in a regulated industry (medical devices/pharmaceutical highly desirable) Education: University bachelor's degree in engineering or Advanced Student in that fields (Industrial, Chemical, Mechanical, Electrical) University master's degree in engineering (Industrial, Chemical, Mechanical, Electrical) preferred Regulation Requirements Quality System Responsibilities Complies with the Quality System Regulation (QSR) Executes job responsibilities as established in the Standard Operating Procedures (SOP) Follows the documentation procedures. Safety & Occupational Health Responsibilities Complies with Safety and Occupational Health Policy and procedures. Complies with Hazardous Communication program. Notifies immediately all accidents or incidents occurred in work area. Promotes and maintains a safe working area and notifies any condition he/she may think might cause an accident. Participates in the activities of the Safety and Occupational Health Program as requested.
