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 software and applications to measure key performance indicators. Strong knowledge of methodology and tools for problem solving and statistical analysis. Proven expertise on equipment and process and/or automation and technical elements. Excellent organization skills, ability to multi-task, and a commitment to timely follow-up; strong results orientation. Ability to establish tools and ways of working to ensure accurate and timely follow-up and on-time deliverables. Able to communicate professionally across a wide variety of employee levels and locations. Strong technical writing, collaboration and presentation skills Bilingual (English/Spanish)

“We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.”

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