Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who 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 a talented, dedicated individual committed to work under the highest ethics standards for the following position:
We are seeking a Computer System Validation (CSV) Specialist with more than five years of experience in the biotech industry to support validation activities for regulated computerized systems. The ideal candidate has hands-on experience using Kneat and is well-versed in CSV requirements within GMP environments.
Key Responsibilities
Support planning, execution, and documentation of computer system validation activities
Develop, execute, and review CSV lifecycle documentation
Ensure computerized systems comply with GMP and regulatory requirements
Support risk assessments, testing, and validation reports
Collaborate with IT, Quality, and Engineering teams
Required Qualifications
Bachelor’s degree in Engineering, Computer Science, or related field
More than 5 years of experience in Computer System Validation within biotech or pharmaceutical environments
Hands-on experience using Kneat
Strong knowledge of GMP, CSV, and data integrity requirements
Validation & Engineering Group, Proudly serving our clients since 1997.
Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.
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 the 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 I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico
Phone: (787) 622-0996
United States:
2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States
Phone: (770) 403-5802
