Project Validation Specialist

For Project Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering or Science and at least five (5) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry. ,
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • Validations such as: packaging equipment, manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities required.
  • Operational Excellence and Lean Six Sigma
  • 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)

• Plans, develops, and implements documentation, procedures, and training necessary for the engineering team, production, and quality personnel.
• Generation and execution of change controls, validation plans, validation protocols (FAT/SAT/IQ/OQ/PQ/CSVs), and completion reports.
• Provide statistical analysis of the data to support the reports.
• Develop statistically based sampling plans for in-process and final testing and inspections and validations.
• Review and approve validations and completion reports for new and existing products, processes, and equipment.
• Troubleshooting equipment/processes that do not perform as intended during validation runs.
• Recommend process/quality improvements as part of validation runs.
• Work with new and existing equipment, processes, utilities, facilities and cleaning validations, to include (but not limited to) Packaging Equipment (e.g. Multivac Machine), freeze-drying, CCA, DIUF, RO/DI, WFI, Pure Steam, SIP Systems, HEPA Filters, chillers, controlled temperature units, and laboratory equipment.
• Evaluate, investigate, and document non-conformance incidents and/or protocol deviations.
• Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.

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?