Sr. Improver-Process (Proyectos)

CooperVision

Alajuela
Permanente
Tiempo completo

Hace 27 días

Job Description:Continuously improves the performance of existing manufacturing processes and equipment through a structured approach.Responsibilities: Essential FunctionsAccountable 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: 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.

About Us:CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture fuel a deeply engaged, high performing organization.CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That's a strong reflection of our corporate culture-and part of the reason CooperVision may be a great workplace for you.

CooperVision

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