Process Development Engineer

For Process Development services in the manufacturing area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor Degree in Engineering and three (3) years of experience in the medical devices industry.
• Bilingual: English and Spanish
• Skills: Writing Skills
• Shift: Administrative, and according to business needs. 
• Experience in:
  • Process and/or equipment validation activities (IQ, OQ, PQ).
  • Responsible for reviewing and developing process validation protocols and reports.
  • Automation systems testing.
  • Process Development and/or Manufacturing Process Engineering.

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

• Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities, and develop Master validation plans.
• 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.
• Be able to manage process development projects from conception to implementation, ensuring project deadlines and objectives are met.
• Familiarity with a variety of technologies and equipment, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, and general experience with automated equipment.
• Experience with the design of experiments (DOE) to characterize and optimize processes.
• Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency, quality, and/or yield of those processes.
• Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

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?