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Summary
About the Role
About You
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- 5+ years of experience in CQV, validation, or technical operations within regulated environments.
- Strong knowledge of cGMPs, validation lifecycle, and regulatory expectations.
- Proven experience with combination products, preferably autoinjector platforms.
- Hands-on experience with automated device assembly equipment, vision systems, and packaging machinery.
- Experience with DFMEA/PFMEA methodologies.
- Willingness to travel internationally for vendor engagements.
- Excellent written and verbal communication skills.
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