jobapplier

Sr. Manufacturing Engineer

fitspr

Skills

Required

  • NPI
  • complex validation data analysis
  • root cause analysis
  • DMAIC model
  • A3s

Preferred

  • Manufacturing Engineering
  • Process Validation
  • Statistical Data Analysis
  • Cause Analysis
  • Troubleshooting
  • DMAIC / A3
  • For Manufacturing services in the Engineering area.
  • In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table.
  • AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

About fitspr

Are you ready to Be The Piece?

  • We are a Service Provider company different from the rest.
  • We pride ourselves in how we treat the most important piece of our company's puzzle: you!
  • We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!).
  • Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent.
  • We're FITS!
  • Are you the Next Piece?

Responsibilities

  • Administrative & according to business needs.
  • Manufacturing Engineering & Technical Project Management Process Validation, Qualification & Statistical Data Analysis Root Cause Analysis, Troubleshooting & Continuous Improvement (DMAIC/A3) The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members.
  • A pply highly developed specialist knowledge and skills in project management, project planning, budgets and methodologies.
  • Manage the most important and challenging projects.
  • Defines project resources, performance reviews and post implementation evaluations.
  • Take ownership of the successful implementation of the projects.
  • Run studies and qualification/validations on the line as needed.
  • Writes protocols and reports with no oversight.
  • Determines overall validation strategy including validation type/requirements, determination of process outputs, sampling plans and performs data analysis.

Requirements

  • The Technical Part: Bachelor’s Degree and minimum five (5) years of experience in regulated industries.
  • Bilingual (Spanish and English).
  • Good organizational and problem-solving skills.
  • Key Responsibilities include, but are not limited to, the following: Apply scientific knowledge, engineering knowledge, mathematics and ingenuity to lead moderately and/or high complex projects with little to no supervision.
  • Ability to execute highly complex or specialized projects.
  • Lead complex technical projects with multiple inter-coordinating elements where problem resolution may involve the application of new methods and/or approaches and may require consideration of impact with other system components and/or users.
  • Lead and/or participate on cross-functional teams to support NPI methodology.
  • Responsible for completing documentation in a timely manner and in accordance with business standards.
  • Provide guidance for validation deviations and complex validation data analysis.
  • Lead root cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s.
  • W ill be accountable on quality, safety and timely implementation of the project.