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25 days old

Senior Validation Scientist - Equipment

Kelly Services
Manatí, PR 00674
**Senior Validation Scientist - Equipment**


Accountable for the design and execution of IQ/OQ/PQ studies of process for parenteral products manufactured at company site. Accountable for designing and executing qualification studies for sterilization/Depyrogenation/bio-decontamination equipment (autoclaves & SIP, tunnel, isolator), utilities and facilities to support their effectiveness in the manufacture of parenteral/oral solid drug dosages products.

Conducts process/packaging equipment installation/operational/performance qualification studies to test their functionality for the manufacture of parenteral products.

Conducts critical sterilization/Depyrogenation/bio-decontamination equipment (tanks, autoclaves & SIP, tunnel, isolator), utilities and facilities qualification studies (Critical utilities/systems includes Purified Water, HVAC, compressed gases) to ensure that a system functions as to routinely produce results that meet predetermined specifications.

Conducts temperature/relative humidity mapping qualification studies (cold boxes, freezers, and incubators) to ensure that a system functions as to routinely produce results that meet predetermined specifications.

Prepares operational qualification assessments to support that validated critical operating parameters are within qualified parameters for specific parenteral products. Identify and evaluate equipment enhancements to support intended qualified operational ranges.

Hands on experience in the use/troubleshooting of validation equipment such as KAYE Validator AVS, thermocouples and temperature/relative humidity data loggers.

Supports the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.


Requirements:


MINIMUM REQUIREMENTS

Bachelor Degree in Pharmacy, Chemistry or Engineering.

Five (5) years of experience in a pharmaceutical industry with at least three to four (3-4) years in parenteral products forms.

Proficient technical knowledge/expertise in pharmaceutical manufacturing processes/technologies and processing equipment for oral dosage forms, including packaging technologies.

Proficient knowledge of equipment/utilities qualification, continuous process improvement and troubleshooting processes.

Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways to equipment/utilities qualification.

Strong project management skills.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-07-18 Expires: 2022-08-18

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Senior Validation Scientist - Equipment

Kelly Services
Manatí, PR 00674

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