CooperVision Senior Process Improver in Alajuela, Costa Rica
CooperVision, a unit of The Cooper Companies, Inc. (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses and related products and services. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com/.
JOB TITLE:Sr. Process Improver
Continuously improves the performance of existing manufacturing processes and equipment through a structured approach.
• 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.
/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.
• Complies with the Quality System Regulation (QSR).
• Executes job responsibilities as established in the Standard Operating Procedures (SOP).
• Follows the documentation procedures.
• Looks for ways to improve and promote quality.
• Applies feedback to improve and promote quality.
• Complies with Safety and Occupational Health Policy and procedures.
• Complies with Hazardous Communication program.
• Notifies immediately all accidents or incidents occurred in work area.
• Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable.
• 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.
· Bachelor degree in Engineering (Industrial, Chemical, Mechanical, Electrical). Master preferred.
Six to ten years of experience with similar responsibilities in a regulated industry (medical devices/pharmaceutical highly desirable).
Title: Senior Process Improver
Location: Costa Rica-Alajuela
Requisition ID: ALA0069