CSV Specialist

For Validation services in the Laboratory area

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Life Sciences or Engineering and previous exposure to Validation & Change Control activities within the Pharmaceutical or Medical Device Industry. 
• Excellent verbal/written communication skills (English and Spanish) 
• Shift: Administrative & according to business needs
• Experience in:
• Change Control Owner 
• CSV 
• Subject Matter Expert managing documentation and validation processes.
• Validation protocols execution (mechanical equipment, CSV & Thermal Mapping) 
• GMP & GDP regulations

The Personality Part:

• If you consider yourself an ingenious and creative problem-solver with an uncanny ability to lead, then this is the job for you! Sprinkle on a love for the scientific method, teamwork, and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on! 

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

• Oversee the lifecycle of change control from initiation to closure, ensuring compliance with regulatory requirements.
• Verify and approve documentation related to equipment changes, ensuring it meets standards.
• Perform validations for mechanical equipment, including operational and performance qualifications.
• Execute CSV to ensure software and systems meet regulatory standards.
• Conduct thermal mapping procedures to ensure temperature-sensitive environments are within specified ranges.
• Work with cross-functional teams to address change control issues and provide guidance.
• Provide necessary documentation and responses during audit activities related to change control and validation.
• Train team members on change control procedures and validation practices.
• Ensure all change control processes adhere to regulatory and company policies.
• Maintain meticulous records and ensure all changes are thoroughly documented and tracked.

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?