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?
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