Job Description

Quality role to support product transfer activities. focused on process validation.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering with at least three (3) years of experience within the regulated industry.
• Bilingual (English & Spanish).
• Good communication skills.
• Shift: 1st and according to business needs.
• Experience in:
  • Sterilization
  • Final Pack
  • Process Validation, Statistical Analysis, Process Failure Mode, and First Time Quality.

The Personality Part:

• Besides being able to provide guidance, you're able to work independently to solve problems and improve every aspect of the project. Add to this a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, and you might just be what we’re looking for!

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

• Conduct a compliant validation process for quality information technology systems, producing all required formal validation documentation, including SOPs, in accordance with applicable federal regulations.
• Coordinate validation‑related activities with clients, programmers/developers, and operating personnel across domestic teams and, when appropriate, global partners.
• Identify current and anticipated requirements for compliant computerized operations and suggest effective methods for establishing, implementing, and maintaining the procedures, actions, and documentation needed to meet federal and international regulatory standards.
• Report on the status of validation activities to ensure regulatory requirements are fulfilled and stakeholders remain informed.
• Stay informed on evolving federal and international regulatory requirements, government audit expectations, and emerging techniques relevant to validation and compliance.
• Perform system administration and configuration tasks for quality information technology systems to support validated and compliant system 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?