Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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:
As a QA Laboratory Systems Specialist, you will serve as the QA system owner for various laboratory computerized systems such as LIMS, Empower, and CDS. You will be responsible for ensuring that these systems remain validated and comply with FDA, cGMP, 21 CFR Part 11, and Data Integrity requirements. Your role will involve participating in system implementation, upgrades, patches, and configuration changes from a QA perspective.
Qualifications:
• Bachelor's degree in a science-related field, preferably in Chemistry or a related discipline.
• Knowledge of computerized system validation (CSV) documentation.
• Familiarity with FDA regulations, cGMP guidelines, 21 CFR Part 11, and Data Integrity requirements.
Responsibilities:
• Oversee and approve change controls, deviations, CAPAs, and incident investigations related to laboratory systems.
• Perform periodic reviews of laboratory systems to ensure continued compliance and suitability for their intended use.
• Review and approve user access management for laboratory computerized systems.
• Support data integrity governance, including adherence to ALCOA+ principles for laboratory data.
• Review and approve SOPs, work instructions, and policies related to laboratory computerized systems.
• Assist in maintaining backup, recovery, disaster recovery, and business continuity plans for laboratory systems.
Additional Information:
• Work Shifts: 1st shift with the possibility of working additional hours and weekends.
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
