Process Improver

The Manufacturing Process Improver continuously evaluates the performance of existing manufacturing operations processes and equipment through a structured approach to achieve efficiency.

Position leads and supports overall manufacturing / production improvement implementation initiatives.

Main Duties and Responsibilities include:


* Creating action plan and guidelines for troubleshooting and advanced improvements.


* Analysis and identification of root and/or possible causes of variation/ failure/ under performance for the assigned business unit.


* End to end documentation (diagnostics, solution method, impact and troubleshooting implementation).


* Process KPI measurements, improvement and reporting (OEE).


* Designing, coordinating and documenting engineering tests/qualifications, among others.


* Ensure readiness and requirement specs for product transfers (from assessment to start-up / implementation and execution).


* Implementation of optimization efforts.

Identifying and Implementing Corrective/ Preventive Actions


* Define and develop requirements for TPM/ PM/ PDM procedures for manufacturing.


* Implement equipment upgrades and optimization changes.


* Ensure compliance with exiting and applicable SOPs, guidelines, laws & regulations (Safety, Calibrations, PMs, among others).


* Administrative matters such as purchase requisitions, project scoping and approvals, SOP revisions, protocols, execution, deviation, reports and improvements,


* Providing technical solutions that increase utilization and cost reduction.


* Supply Chain performance indicators, area RM usage optimization, unit MRO, spare parts usage, insert inventory supply.


* Capital / infrastructure projects.


* Collaborating for Quality first pass, DPM & CPM metrics and overall QA and awareness.


* Provide training and/or process refreshers to ensure area resources have required skills and knowledge in support of improvements and projects.


* Developing process and regulatory documentation for automation systems


* Shutdown Planning and Execution


* Overall resource and material monitoring, optimization, cost efficiency and modeling for process improvements.


* Material, supplier and overall compliance and proactive, preventive problem solving.


* Data gathering, evaluation, investigation and initiation and closure of quality, process and related issue resolution.


* Implementing safety corrective actions and non-conformance resolution.

Education:


* Bachelor's degree in life sciences or engineering required.


* Advanced (master's) degree, Lean Six Sigma, or technical certifications, EIT license, CIAPR membership highly desirable.

Experience:


* One year of related manufacturing, operations, process improvement experience.

within the regulated industry required.

Medical devices exposure highly preferred.

Knowledge, Skills, and Abilities:


* Proficiency using softwar...