FITS, LLC
WHAT MAKES YOU A FIT
Be among the first 25 applicants for Validation support services in the Manufacturing & Engineering area.
The Technical Part
Bachelor’s degree in Life Sciences or Engineering and previous exposure in Validation Life Cycle activities within the Pharmaceutical or Medical Device industry.
Shift: Administrative & according to business needs
Bilingual: (Spanish and English)
Experience in:
Process, equipment, cleaning, and software validation.
Develop, execute, and document validation protocols and reports.
Troubleshooting and root cause analysis.
Risk assessment tools (FMEA, HACCP, risk matrix).
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 take on this new challenge?
AS A PIECE OF FITS, YOU WILL
Knowledge of validation methodologies (IQ, OQ, PQ) and protocols.
Familiarity with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and FDA/ISO regulatory requirements.
Proficient in using data analysis tools (Excel, Minitab, or equivalent).
Strong analytical and problem-solving skills. Excellent technical writing and documentation skills.
Willingness to work in cleanroom or controlled environments.
Knowledge of safety procedures and compliance with EHS regulations.
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.
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.
Are you the Next Piece? Seniority level Entry level
Employment type Full-time
Job function Sales, General Business, and Education
Industries Wireless Services, Telecommunications, and Communications Equipment Manufacturing
#J-18808-Ljbffr
The Technical Part
Bachelor’s degree in Life Sciences or Engineering and previous exposure in Validation Life Cycle activities within the Pharmaceutical or Medical Device industry.
Shift: Administrative & according to business needs
Bilingual: (Spanish and English)
Experience in:
Process, equipment, cleaning, and software validation.
Develop, execute, and document validation protocols and reports.
Troubleshooting and root cause analysis.
Risk assessment tools (FMEA, HACCP, risk matrix).
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 take on this new challenge?
AS A PIECE OF FITS, YOU WILL
Knowledge of validation methodologies (IQ, OQ, PQ) and protocols.
Familiarity with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and FDA/ISO regulatory requirements.
Proficient in using data analysis tools (Excel, Minitab, or equivalent).
Strong analytical and problem-solving skills. Excellent technical writing and documentation skills.
Willingness to work in cleanroom or controlled environments.
Knowledge of safety procedures and compliance with EHS regulations.
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.
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.
Are you the Next Piece? Seniority level Entry level
Employment type Full-time
Job function Sales, General Business, and Education
Industries Wireless Services, Telecommunications, and Communications Equipment Manufacturing
#J-18808-Ljbffr