Process Engineer

For Validation services in the Engineering and Manufacturing area.

WHAT MAKES YOU A FIT:

The Technical Part:

Bachelor’s degree in Engineering and a minimum of five (5) years of exposure in Validation activities within the Pharmaceutical or Medical Device Industry.

Excellent verbal/written communication skills (English and Spanish)

Shift: Administrative & according to business needs

Softwares: MS Office (Word, Excel, PowerPoint), Maximo

Experience in:

Validation Life Cycle (IQ, OQ, PQ, CSV, FAT)

Control Systems, Automation and Vision Systems

Packaging area

GMP & GDP regulations

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)

Write, execute and maintain on a timely basis Validation protocols.

Ensure timely, thorough and complete execution of all protocols, meeting FDA requirements.

Ensure that all new and existing protocols are effectively integrated into manufacturing processes.

Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.

Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing.

Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements.

Responsible for developing and implementing process strategies, optimizing current processes, and maintaining process documents.

Support the day to day process operations.

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?