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.
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 (, Electrical)Electromechanical, Mechanical. Master, preferred.
Six to ten years of experience with similar responsibilities in a regulated industry (medical devices / pharmaceutical highly desirable).
CooperVision®, Inc. is an EEO / AA Employer M / F / D / V