Detail of : Senior Validation Scientist - Equipment Job Openings in Manatí
For validation services in the manufacturing area
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s degree in Pharma, Chemistry or Engineering & five (5) years of exposure in the Pharmaceutical industry.
Three (3) years in solid oral dosage forms.
Ten (10) years in validation life cycle.
Technologies and processing equipment for oral dosage forms, including packaging technologies.
Validation Life Cycle: IQ/OQ/PQ for equipment/utilities.
The Personality Part:
We’re looking for a confident people-person, who’s a great leader (people listen to you!) and effective decision-maker. Add to this a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, and you might just be what we’re looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Design and execute IQ/OQ/PQ studies of process for parenteral and oral solid drug dosages products manufactured, Depyrogenation/bio-decontamination equipment (autoclaves & SIP, tunnel, isolator).
Conduct process/packaging equipment IQ/OQ/PQ studies to test their functionality for the manufacture of parenteral and OSD products.
Conduct temperature/relative humidity mapping qualification studies (cold boxes, freezers, and incubators).
Troubleshoot validation equipment such as KAYE Validator, thermocouples, and temperature/relative humidity data loggers.
Support the evaluation of Change Controls, process capability and statistical analysis related to equipment performance within parenteral and OSD manufacturing process.
Serves as SME for qualifications during regulatory audits (internal and external).
Investigate and conduct troubleshooting and root-cause analysis
Prepare protocols in compliance with corporate guidelines, procedures, FDA Regulations and industry current practices.
Execute activities according to the Time and Event schedule developed by the site team.
Perform in-process tests as required, analyze qualification data and generate conclusion, successful and on-time resolution of incidents and deviations related to equipment/utilities qualification exercises.
Identify, plan, and implement quality and productivity initiatives associated to equipment/utilities qualification activities based on business needs and priorities.
BEING A FITS PIECE COMES WITH PERKS:
One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!
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!
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For more detail information about the program, please refer official source from FITS LLC on following link below. If you meet these requirements, please register yourself at :
All applications will be treated confidentially.
Only short-listed candidates will receive responses.
If you are not interested in Senior Validation Scientist - Equipment Manatí October 2020 FITS LLC above, you can try to find your job by read related jobs from another company in Manatí below.
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