Manufacturing Engineer Medical DevicesPharma

Job Description:Experience with Validation (IQ/OQ/PQ)Product Transfers – preferred, but not requiredExperience with Capital Projects, Continuous Improvement, or Cost Improvement ProjectsEngineer with a minimum of 2 years of experience working with validations in the Medical Device or Pharmaceutical industryExcellent communication skillsMust be able to speak and write in both Spanish and EnglishAbility to work with minimum guidance / limited supervision
Responsibilities:Design, communicate, and implement an operational plan for completing the project.Monitor progress and performance against the project plan.Take action to resolve operational problems and minimize delays.Identify, develop, and gather the resources to complete the project.This may include preparing engineering designs and work specifications, develop project schedules, budgets and forecasts, and select materials, equipment, project staff, and external contractors.Liaise with other operational areas in the organization (e.g. engineering, drafting, technical) to secure specialized resources and contributions for the project.Conduct meetings and prepare reports to communicate the status of the project.Set priorities, allocate tasks, and coordinate project staff to meet project targets and milestones.Runs studies and validations on the line as needed.Leads statistical analysis for projects.Considers risk mitigation in planning based on lessons learned or from peers. Reviews previous similar projects and activities as part of the decision-making process. Anticipates potential situations that may impact projects timeline and resolve them before they become an issue.Can generate and approve qualification and validation protocols and reports with minimal oversight.Is the technical liaison with other cross functional areas with other sites from client.