Quality Labeling Engineer

Job DescriptionJob DescriptionValidation & 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:Labeling EngineerJob Summary:The Quality Labeling Engineer provides on-site technical support for labeling (for example system and artwork update implementation) and regulatory compliance projects (for example MDD / EU MDR related implementations). Possesses technical responsibility for interpreting, organizing, executing, coordinating, and carrying out assignments based on defined requirements and strategies. Job Responsibilities:Serves as point of contact between Division and site for packaging/labeling requirements updates.Supports the development of component specification.Coordinates with Planner/Buyer the purchase and delivery of new packaging components.Maintains contact with Suppliers of Packaging Components as required.Development and execution of Component Qualifications (including Protocols / Reports Generates redlines to update SOPs, MPS, IPs, WIMs among other documents.Generates change request (CRs) for the approval of the required documentation updates.Close communication with stakeholders such as Manufacturing areas, Supply Chain, RA, Document Control and Division representatives.Responsible to maintain tracking of assign tasks status and provide updates as required.Complies with cGMP’s, Quality Standards, and established policies and proceduresExecutes other duties assigned by his supervisor.Assures is trained before performing any task.Uses the required clothes, personal and security protective equipment according to the requirements of its operation.Complies with the cGMP’s, Quality Standards and established policies and/or proceduresEducation and Experience:Bachelor’s Degree in Engineering.Experience in the Medical Device / Pharmaceutical Industries is desirable.Previous experience in the following fields is a plus:ManufacturingComponent QualificationsDemonstrated ability to plan and manage multiple projectsExcellent interpersonal skills including the ability to interface and communicate effectively at all levels, both inside and outside the organization.Knowledge and Skills:Working knowledge of US FDA and International regulations governing the medical device industry, i.e., QSR, GMP, MDR, and ISO 13485.Knowledge of fundamental quality systems principlesKnowledge in Qualification / Validation (IQ/OQ/PQ), Packaging Validation and Labeling VerificationDemonstrated critical thinking skills and problem-solving skills.Ability to deal effectively with all levels of management.Excellent communication and technical writing skills in both English and SpanishComputer Literate: Microsoft Office (Power Point, Word, Excel) among othersTeamwork orientedMust have good independent judgment and a demonstrated ability to set priorities Be able to maintain multiple ongoing tasks on a tight deadline and work at a fast paceAbility to work in a cross-functional team environment, as well as the ability to function independently.