Job Description

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:

• Labeling Engineer

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 procedures
• Executes 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 procedures

Education 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:
  • Manufacturing
  • Component Qualifications
• Demonstrated ability to plan and manage multiple projects
• Excellent 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 principles
• Knowledge in Qualification / Validation (IQ/OQ/PQ), Packaging Validation and Labeling Verification
• Demonstrated 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 Spanish
• Computer Literate: Microsoft Office (Power Point, Word, Excel) among others
• Teamwork oriented
• Must 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 pace
• Ability to work in a cross-functional team environment, as well as the ability to function independently.