Process Development Engineer

For Process Development services in the automation and validation area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor of Science in Engineering and at least four (4) years of experience in Project Management within the Pharmaceutical Industry.
• Shift: Administrative and according to business needs. 
• Bilingual: English and Spanish (verbal/written). 
• Experience in:
  • Support process and/or equipment validation activities (IQ, OQ, PQ). 
  • Manufacturing processes ( Laser Welding, Heat Bonding, Injection Molding, Vision Systems, automated equipment). 
  • Responsible for reviewing and developing process validation protocols and reports.

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)

• Support process and/or equipment validation activities; process performance qualification, and develop Master validation plans for new processes. 
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
• Work with the Process Development team to efficiently qualify new processes; assist with statistical sampling plans, and other development procedures.
• Design and develop in-process and receiving quality systems for new processes and components.
• Generate equipment documentation, such as equipment entries, evaluations, PM, and calibration procedures, as required.
• Be able to manage process development projects from conception to implementation, ensuring project deadlines and objectives are met.
• General experience with automated equipment (PLC/Servos/Pneumatics/ Sensors), etc.
• Experience with design of experiments (DOE) to characterize and optimize processes, as well as analyze the resulting data.
• Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency, quality, and/or yield of those processes that are being developed.
• Understand and evaluate the risks associated with these manufacturing processes and develop ideas/solutions to minimize these risks. 

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?