6 LL01-062824 Validation Specialist Jobs in Raleigh, NC
Validation & Engineering Group is Hiring a LL01-062824 Validation Specialist Near Raleigh, NC
Job Description
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking for talented, dedicated individuals who are committed to work under the highest standards of ethics to and with expertise in the following areas:
- Process Equipment and Utilities IQ/OQ
- Computer System Validation (CSV)
- Experience with the qualification of several of the following equipment and processes:
- HVAC, environmental monitoring, Laminar Flow Hoods, CIP/SIP skids, Freezers, Parts Washers, Autoclaves, Isolators, Vacuum Pumps, Debagger, Delidder, Syringe Filling Machines, Syringe Inspection, Peristaltic Pumps, Gas Monitoring, Filter Integrity Testers, VHP Generators, Material Transfer Isolators, Check Weighs, Portable Tanks, Oxygen Sensor, Heat Exchangers, PH Meter, TCU, Scales/Balances, Sterilization and decontamination processes with VHP generators, Automation Control Systems, BAS systems.
- Able to work independently.
Qualifications:
- Bachelor's Degree in Science or Engineering
- Minimum of 4 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Experience in IOQs within direct process / manufacturing areas.
- Must be proficient using MS Windows and Microsoft Office applications.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance, i.e. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFR's, ISPE Good Automated Manufacturing Practice (GAMP).
- Kneat experience valuable.
Job Summary
Full Time
$71k-86k (estimate)
08/12/2024
08/25/2024
veg-group.com
GUAYNABO, PR
50 - 100
1997
LUIS F PUIG
<$5M
Business Services
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About Validation & Engineering Group
Validation & Engineering Group, Proudly serving our clients since 1997. Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage. Our agility in responding to our clients needs, access to the best pool of talent, and t...he combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries. At Validation & Engineering Group we provide professional expertise in the areas of: Audit and Assessment Automated Process Control System Qualification Equipment and Facilities Qualification Facilities Start-Up and Commissioning GAP Analysis Information Systems Computer Validation Packaging and Process Analysis Process & Cleaning Validation Project Management Quality Systems Risk Based Approach Regulatory Compliance Standard Operating and Maintenance Procedures Training Utilities Support and Qualification In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical. Our Offices: Puerto Rico: Centro Internacional de Mercadeo I100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico Phone: (787) 622-0996 United States 2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States Pjone: (770) 403-5802
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