Job Opportunities in Costa Rica

• 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 (Power Point, 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.

• 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.

• 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

• 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

• 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