For Validation services in the PD area.
WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with five (5) years of exposure as a Validation Specialist within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills.
Shift: Administrative and according to business needs.
Experience in: URS, DS, and Equipment Risk Assessments Characterization and Validation experience Development of Characterization and Validation protocols Execution of Characterization and Validation protocols Device assembly equipment and packaging equipment validation experience 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 modifications and/or capital projects.
Develops, organizes, analyzes, and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
Complete complex or novel assignments requiring developing new and/or improved validation engineering techniques and procedures.
Develop validation engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate, and review the 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 the area of validation engineering expertise.
Apply knowledge of validation engineering principles and practices outside of one's area of expertise to a wide variety of assignments in related fields.
Develop technical solutions to complex problems requiring regular ingenuity and creativity.
Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance to develop requirements and recommendations for large and/or highly complex process, system, and facility modifications.
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 the area within the project or the entirety of the smaller project.
Prompt and regular attendance at the workplace.
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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