Sr. Manufacturing Engineer

FITS LLC; Caguas (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS LLC is a service provider delivering Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island and in the US. We seek a Manufacturing Engineering Project Manager who can lead complex projects, apply DMAIC/A3, and ensure quality, safety and timely implementations across partnerships with pharmaceutical and manufacturing clients.

You will collaborate with cross-functional teams, document protocols, and drive process validations while upholding our

Qualifications

• Bachelor’s Degree and minimum five years of experience in regulated industries.
• Shift: Administrative & according to business needs.
• Experience in Manufacturing Engineering & Technical Project Management; Process Validation, Qualification & Statistical Data Analysis; Root Cause Analysis, Troubleshooting & Continuous Improvement (DMAIC/A3)

Responsibilities

• Lead moderately to highly complex projects with little to no supervision.
• Manage project resources, budgets and planning.
• Define resources, performance reviews and post-implementation evaluations.
• Take ownership of successful project implementation.
• Lead cross-functional teams to support NPI methodology.
• Document activities in a timely manner per business standards.
• Run validation studies on the line and write protocols/reports with minimal oversight.
• Provide guidance for validation deviations and complex data analysis.
• Lead root cause analysis for high complexity manufacturing events.

Skills

Project management

DMAIC

Root cause analysis

Statistical data analysis

Process validation

Quality systems

Budgeting

Bilingual SP-EN

Manufacturing engineering

Education

Bachelor’s Degree

Tools

Minitab

Excel

JMP

Job description

For Manufacturing services in the Engineering area.

WHAT MAKES YOU A FIT:

THE Technical Part:

• Bachelor’s Degree and minimum five(5) years of experiencein regulated industries.
• Bilingual (Spanishand English).
• Good organizational and problem-solvingskills.
• Shift: Administrative& according to business needs.
• Experience in:
  • 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. 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. Are you ready to Be The Piece?

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

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.
• Applyhighly developed specialist knowledge and skills in project management, project planning, budgets and methodologies.
• Managethe most important and challenging projects.
• Defines project resources, performance reviews and post implementation evaluations.
• Takeownership of the successful implementation of the projects.
• 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.
• 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.
• Provideguidance for validation deviations and complex validation data analysis.
• Leadroot cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s.
• Will be accountable on quality, safety and timely implementation of the project.

WHO WE ARE:

We are a Service Provider companydifferent 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 industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?