Validation Engineer

For Validation services in the Quality/Validation area.

WHAT MAKES YOU A FIT:

The Technical Part:

Bachelor’s degree in Engineering and at least two (2) years of previous experience in Validation activities within the Pharmaceutical & Medical Devices Industry.

Bilingual: Spanish and English

Soft Skills: Excellent communication skills and a positive attitude.

Shift: Administrative and according to business needs

Experience in:

Validation Life Cycle (IQ, OQ, PQ)

Manufacturing processes, equipment, cleaning, and computerized systems validation

Regulatory requirements and standards (FDA, ISO, cGMP)

Statistical analysis tools (e.g., Minitab, Excel)

Change Control and validation impact assessments

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 Be The Piece?

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

Develop, execute, and document validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Support validation activities for manufacturing processes, equipment, cleaning procedures, and computerized systems.

Participate in equipment qualification, requalification, and validation lifecycle activities to ensure compliance and operational readiness.

Perform validation impact assessments associated with Change Controls (CN/CR) and support implementation activities.

Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, R&D, and Regulatory Affairs to support validation projects.

Analyze validation data using statistical tools and methodologies to support conclusions and recommendations.

Support protocol deviations, investigations, corrective actions, and continuous improvement initiatives.

Maintain accurate validation documentation in compliance with Good Documentation Practices (GDP) and applicable regulations.

Support internal audits and regulatory inspections by providing validation documentation and technical expertise.

Track validation project timelines, deliverables, and status updates to ensure successful execution.

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?