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:

Medical Devices Project Technician

Job Summary

Independently, or under limited or null supervision, works on complex by nature assignments, which require considerable criteria, judgment and initiative in order to solve problems and issue recommendations. The project technician is responsible for implementing, modifying and monitoring the equipment functionality within the project scope. Assists engineers with developing, implementing and maintaining new/modified/current production processes, tools and equipment. They are responsible for ensuring that all activities assigned to them in designated manufacturing lines is performed, keeping the expected levels of the Department in the GMPs (Good Manufacturing Practices). Compliance with Good Manufacturing Practices (GMPs) making observations and communicating them to their supervisor for their correction.

Duties and Responsibilities

• Identifies/documents operational control standards and testing equipment to assess conformance with engineering specifications.
• Set up test apparatus and conducts tests of raw materials, parts, components, finished items and packaging.
• Troubleshoots and resolves technical equipment problems to minimize finished item rejection levels.
• Monitors gauges, dials and other indicators of production equipment/machinery performance.
• Writes technical reports in a moderate complex manner, using graphics, and schemes to describe and illustrate operative characteristics of the system/tests, as well as dysfunctions, deviations about the specifications of designs and functional limitations.
• Solves problems related to the systems, components and electrical equipment, testing, mechanical, hydraulics or of installation.
• Performs basic operational diagnostics tests, solves problems and disconnects components, subassemblies and manufacturing systems, processes and equipment with the purpose of isolating the failures, determining a solution and performing the necessary operations. Documents all the changes.
• Ensures that the tools and testing equipment are properly calibrated and repaired, according to the standardized operations procedures.
• Provides support in the installation and validation processes of equipment required in the assigned area.
• Provides support and/or generates Engineering changes or CN/CRs.
• Follows the Convenient Information Retention Administration Policies of the Campus, record retention program, training and education, Document Retention Notices, Record cleanup, inactive records and Information Management, Vital Records if applicable.
• Other responsibilities can be assigned and not all the responsibilities listed here must be assigned.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Willing to travel to other locations as needed.
• Passport required.

Experience and Education

• Technical Certificate
• Preferably trained in two or more of the following disciplines: electronics, mechanics, production, electro-mechanics, testing, quality and production, process statistical control, biomedics or industrial engineering.
• Generally, Requires 2-4 Years Work Experience
• Preferred ability to communicate effectively in English and Spanish across functions and both internally/externally

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

• Ability for the resolution of failures, in aspects or areas of manufacturing.
• Ability to integrate into work groups.
• Knowledge of preventive and corrective maintenance, documentation, calibration procedures and quality systems, preferably.
• Knowledge of the product manufactured by the Company.
• Ability to use measuring and testing equipment associated with specific discipline.
• Basic ability to read and understand technical documentation associated with specific discipline.
• Capacity to successfully complete the departmental/corporate courses of training in manufacturing techniques.
• Ability to learn about regulatory requirements (GMP and GDP).
• Ability to use computers and related software.
• Ability to learn and adhere to specific procedures according to the department training plan
• Able to work in a Clean Room environment requiring gowning.
• Must have strong communication and interpersonal skills and be able to support cross functional teams including Quality, Operations & Engineering.