Kelly Services
Location
Puerto Rico | United States
Job description
Kelly® Science & Clinical is seeking Sr Validation Scientist-Equipment for a 12 month contract position at a Global Pharmaceutical client in Manati, Puerto Rico. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Salary: $50.32 per/hour
Overview
This client is Global Biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
In this role you’ll be accountable for the design and execution of IQ/OQ/PQ studies of process for parenteral products manufactured. Accountable for designing and executing qualification studies for sterilization/Depyrogenation/bio-decontamination equipment (autoclaves & SIP, tunnel, isolator), utilities, facilities and cleaning to support their effectiveness in the manufacture of parenteral/oral solid drug dosages products.
This role will give you an opportunity to transform patients’ lives through science by contribute with a global leading biopharma company powered by talented individuals who drive scientific innovation.
Schedule: 8am-5pm.
Able to work extra hours if it required by the company.Responsibilities:
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.
Supports process capability and statistical analysis related to equipment performance within parenteral manufacturing process
Qualifications:
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.
Proficient in design and execution of IQ/OQ/PQ studies of process for parenteral products manufactured.
Technical writing and oral communication skills (English/Spanish).
What happens next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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