Sr Validation Scientist

Flexible & Integrated Technical Services, LLC • Juncos, PR

1d

About The Position

For Validation Services in the Quality Assurance area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree with four (4) years of experience in a Scientist within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills.
Shift: Administrative, and according to business needs.
Experience in:
Validation in Parenteral Manufacturing.
Aseptic Process Validation, Aseptic Techniques, Environmental Monitoring Performance Qualifications, Environmental Characterizations.
Writing protocols and reports and executing inside clean rooms.
The Personality Part:
Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Able to troubleshoot systemic validation issues.
Applies advanced and diverse validation engineering principles to the design and implementation of major system or process.
Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope.
Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
Develop validation engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations.
Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints.
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
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?

Requirements

• Bachelor's Degree with four (4) years of experience in a Scientist within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Validation in Parenteral Manufacturing.
• Aseptic Process Validation, Aseptic Techniques, Environmental Monitoring Performance Qualifications, Environmental Characterizations.
• Writing protocols and reports and executing inside clean rooms.

Responsibilities

• Able to troubleshoot systemic validation issues.
• Applies advanced and diverse validation engineering principles to the design and implementation of major system or process.
• Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope.
• Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
• Develop validation engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
• Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations.
• Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level