Manufacturing/Validation Engineer

For engineering services in the manufacturing area. 
WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and two (2) years of experience in the Pharmaceutical or Medical Device industry.
• Bilingual (English & Spanish). 
• Project Management skills. 
• Shift: Administrative and according to business needs. 
• Experience in:
  • Validations, protocol writing in a regulated manufacturing environment.
  • Application and principles of Manufacturing/Process
    Engineering.
  • Effectively communicate cross-functionally to assist with resolving
    Quality/Engineering issues.
  • Office applications: Word, PowerPoint, Excel.

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 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 take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Responsible for coordination of product builds through the NPI processs.
• Generates all types of changes to the eLHR system.
• Demonstrates basic understanding of regulations (Compliance and EHS) for work area. Provides recommendations for improvement and executes as needed.  
• Supports EHS and/or Reg Compliance audits
• Knowledge of Packaging Engineering Concepts, including packaging validation requirements and materials interaction.
• Minimal oversight required for problems or assignments of reasonable difficulty. Makes decision in a efficient manner.
• Considers risk mitigation in planning based on lessons learned or from peers. Reviews previous similar projects and activities as part of the decision making. 
• Prepares and provides well thought out contribution to meetings. Provides technical guidance to peers that facilitates the progression of the project, group or person.
• Can present information and collaborates with peers across functions (both internally and externally) . Exposure to cross functional mgmt. communications.
• Responsible for product/process knowledge and understanding of basic cause and effect of line and process changes.
• Responsible for providing the line with related Engineering fixes, such as tooling (TLTs) and Manufacturing Aids( from idea definition to implementation).
• Support maintenance technicians and supervisors in equipment availability issues.
• Responsible for determining quality impact of Out-of-Tolerance documents.
• Responsible for execution of line related change management (material, equipment and process changes).
• Responsible for simple continuous improvement projects development and execution.
• Runs studies and validations on the line as needed. Writes protocols and reports with oversight.

WHO WE ARE:

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?