Process Development Validation Engineer

For Process Development and Validation and manufacturing area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor Degree in Engineering and five 5 years of experience in the regulated industry.
• Bilingual (English and Spanish).
• Administrative and according to business needs. 
• 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.
• Experience in:
  • Process and/or equipment validation activities (IQ, OQ, PQ).
  • Responsible for reviewing and developing process validation protocols and reports.
  • Functional areas during the validation activities.

The Personality Part:    

• If you feel a passion for transforming lives and innovating with new medical solutions, using global collaboration, high performance, diversity and winning spirit, then this is a job for you.

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 for new processes or products.
• 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 on 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. 
• Define gages, tools and equipment for the test methods developed.
• Generate manufacturing instructions for new processes being developed
• Work cross-functionally with other departments to accomplish PD tasks.

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?