Job Description

For Quality Engineering - Global Manufacturing Operations services in the Manufacturing area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Engineering or Life Sciences and three (3) to five (5) years of exposure to Quality Validations within the regulated industry.
• Lean Six Sigma certification preferred.
• Bilingual English/Spanish, both written and verbal
• Shift: Administrative and according to business needs.
• Experience in:
• Developing, Executing, and Reviewing Validations Life Cycles Protocols.
• Testing and Development of Statistical Process Control.
• Medical Device industry is a definite plus.
• Validation design, testing and development of statistical process control and monitoring.
• Product design, costing and production requirements.

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 take on this new challenge?

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

• Able to evaluate systems, implement validation packets, and identify existing or potential gaps
• Provides validation to technology/manufacturing systems in support of manufacturing sites for in-line products and processes
• Provides tactical direction and guidance for project teams implementing various activities for new and existing GMP systems.
• Develops and reviews Standard Operating Procedures (SOPs).
• Provides support for ongoing compliance initiatives, assessments, corrective actions, and training.
• Based on equipment capabilities, generate and execute quality validation protocols (IQ, TMV, TQF, Process Characterization, and Process Validation).
• Conduct validation of process equipment installation/operational/performance qualification studies to test their functionality.
• Prepare operational qualification assessments to support the fact that validated critical operating parameters are within qualified parameters.
• Identify and evaluate equipment enhancements to support intended qualified operational ranges.
• Support the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.
• Support process capability and statistical analysis related to equipment performance

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?