Sr. Improver-Process (Proyectos)

Accountable for:

1. Coordinating production improvements implementation


2. Creating troubleshooting guidelines and/or applicable SOPs and equipment maintenance and repair


3. Identifying possible causes of variation/ failure/ under performance for Manufacturing.


4. Document diagnostics, solution method and impact in troubleshooting for Manufacturing.  


5. Measuring Process KPIs for improvement


6. Analyzing through a structured approach to identify root causes.


7. Improving Process KPIs performance


8. Developing control mechanism to ensure Process KPIs consistency.


9. Designing and Coordinating Engineering Tests/ Q's


10. Executing Engineering Tests/ Q's


11. Documenting and Reporting Results of Engineering Tests/ Q's


12. Assuring Readiness of Manufacturing Requirements for the Product Transfer


13. Receiving and Implementing Product and Equipment Transfer


14. Observing, Analyzing, Documenting & Recommending the Start-up of Product Transfer


15. Assuring Operator and BU's resources have the Skills and knowledge coming from change due to Optimizations.


16. Implementation of Optimization Efforts


17. Defining Manufacturing equipment maintenance requirements


18. Developing TPM/ PM/ PDM procedures for Manufacturing Equipment


19. Verifying TPM/ PM/ PDM tasks effectiveness in Manufacturing.


20. Ensuring correct resources are acting upon situation for Equipment Repair


21. Correcting troubles in Manufacturing under performance situation using troubleshooting guidelines and/or applicable SOPs


22. Measuring Equipment Efficiency


23. Identifying Opportunities for Improvements in Equipment Performance


24. Implementing Equipment Upgrades and Optimization Changes


25. Writing Validation Documentation and Test Protocols


26. Documenting all Equipment Changes


27. Assuring Compliance with Laws & Regulations 


28. Generation of Purchases Requisition


29. Submitting Scope and Approve Projects


30. Submitting Documentation for Safety Compliance, New Equipment Calibrations, Calibration extensions and Preventive Maintenance


31. Systems & Equipment PM's SOP's Revisions/ Improvements


32. Evaluating Needs for Infrastructure Projects and Start-ups


33. Submitting MSDS as Required

Assist in:

1. Supply Chain Performance Indicators Improvement


2. Unit RM Usage Optimization


3. Unit MRO, Incl. Spare Parts Usage Optimization


4. Quarterly Capex meeting with Projects and Owners Team


5. Defining Tactics for Quality First Pass, DPM & CPM Metric (Once a Year)


6. Quality Documentation Approval


7. Quality Awareness


8. Identifying and Implementing Corrective/ Preventive Actions


9. Preparing Rework Protocols or memos for NCRs


10. Investigating NCR, Quality Feedback and Complaint


11. Developing Actions to improve Quality KPI's


12. Developing Procedures for QI


13. Providing Training for QI


14. Providing Support for the QI Start-up


15. Defining and Prioritizing Process KPIs for improvement


16. Writing validation documentation (protocols)


17. Protocol Approval


18. Developing process and regulatory documentation for automation systems


19. Performing and documenting engineering studies


20. Early Involvement in Transference Effort with Technical Innovations (ROI)


21. Assuring Operator and BU's resources have the Skills and knowledge to receive the Product Transfer


22. Early Involvement in LS /Optimization Efforts with Technical Innovations (ROI)


23. Assuring Readiness of Manufacturing Requirements for the Optimization Efforts


24. Identifying possible causes of variation/ failure/ under equipment performance for Manufacturing.


25. Procedure Approval for skills certifications


26. Technical Academy design and delivery


27. Optimizing Unit Performance


28. Shutdown Planning and Execution

Active Participation:

1. Inserts Inventory Supplies


2. Unit MRO, Incl. Spare Parts Price Optimization Awareness   


3. Unit MRO, Including Spare Parts Inventory Optimization 


4. Plant RM & MRO Leverage Opportunities


5. Unit Capacity Utilization $'s


6. Cost Modeling for Process Improvement


7. Material Quality issues avoidance


8. Monitoring Supplier's Performance


9. Evaluating Quality Issues Reports at Manufacturing. & QA Final


10. Investigation (Data gathering of Quality issue)


11. Evaluating NCR Actions Effectiveness


12. Initiating Non-Conformance Resolution


13. Evaluating NCR 


14. Leading Improvement Activities


15. Developing supporting Documentation for QI


16. Implementing Safety corrective actions 


17. Safety Non-Conformance Resolution 


18. Identifying process and/or Manufacturing equipment not performing as expected


19. Ensuring correct resources are acting upon situation for Manufacturing.


20. Designing and programming of Process automation improvement systems


21. Providing technical solutions that increase utilization and reduce costs.


22. Improving accuracy Automation System requirements and specifications for the development of SCADA and other systems


23. Reviewing/ Modifying Standard Operating Procedures for Engineering Controls


24. Final selection of resources 


25. Test Design for skills Certifications


26. Preparing Training Module for skills certifications


27. Budget Development and Administration


28. Monitoring Unit Performance


29. People Development


30. Providing Capabilities to Work Unit 

1. Knowledge of FDA current GMP/QSR regulation


2. Excellent oral and written communication skills in both English and Spanish languages


3. Teamwork and service oriented


4. Effective leadership


5. Computer literate (PowerPoint, Word, Excel)


6. Willing to Travel


7. Excellent interpersonal skills


8. Highly Motivated, self-starter and responsible person 

• 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)

• Six to ten years of experience with similar responsibilities in a regulated industry (medical devices/pharmaceutical highly desirable)

• 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

1. Complies with the Quality System Regulation (QSR)


2. Executes job responsibilities as established in the Standard Operating Procedures (SOP)


3. Follows the documentation procedures.

1. Complies with Safety and Occupational Health Policy and procedures.


2. Complies with Hazardous Communication program.


3. Notifies immediately all accidents or incidents occurred in work area.


4. Promotes and maintains a safe working area and notifies any condition he/she may think might cause an accident.


5. Participates in the activities of the Safety and Occupational Health Program as requested.