Validation Engineer

FITS, LLC; Añasco (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Validation Engineer to support engineering validations in the Pharmaceutical or Medical Device sector. The role requires an Engineering degree and hands-on validation, Lean manufacturing, and GMP/GDP experience.

You will write and execute validation protocols, ensure FDA-aligned documentation, and contribute to process improvements while collaborating with a tight-knit team. Bilingual English/Spanish communication is essential, and the shift is administrative,

Qualifications

• Bachelor’s degree in Engineering with 3+ years in Validation/Lean Manufacturing in pharma/medical devices.
• Shift is administrative and varies with business needs.
• Experience with Validation Protocols.
• Experience with Lean Manufacturing.
• Knowledge of GMP & GDP regulations.

Responsibilities

• Write, execute, and maintain validation protocols.
• Ensure timely, thorough execution of all protocols meeting FDA requirements.
• Integrate new/existing protocols into manufacturing processes.
• Ensure documentation is thorough and entered on time into the quality system.
• Investigate product/batch deviations and validation sampling issues.
• Document investigations and communicate findings to minimize recurrence.
• Develop and implement process strategies and maintain process documents.
• Support day-to-day process operations.

Skills

Validation Protocols

Lean Manufacturing

GMP/GDP regulations

Verbal communication

Written communication

Bilingual English/Spanish

Education

Bachelor's degree in Engineering

Job description

For Validation servicesin the Engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s degree in Engineeringand a minimum of three(3) years of exposure in Validation and Lean Manufacturing activities within the Pharmaceutical or Medical Device Industry.
• Excellent verbal/written communication skills (English and Spanish)
• Shift: Administrative & according to business needs
• Experience in:
  • Validation Protocols
  • Lean Manufacturing
  • 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 protocol.
• 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 companydifferent 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 industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?