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Equipment Validation Technician

Plano, TX 75024

Posted: 04/09/2024 Employment Type: Contract Job Category: Engineering Job Number: 603910 Is job remote?: No Country: United States

Job Description

Target PR Range:
*Depending on experience

This role will execute engineering duties within the Operations Engineering organization. Ensures engineering readiness to support production and product transfer activities. Works within company Quality Management System.

RESPONSIBILITIES:
• Executes installation, setup and qualification of manufacturing equipment.
• Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols and reports, risk assessments, and procedures and other technical documents to insure compliance, efficient and safe procedures.
• Suggests and supports new methods or materials for continual improvement in the quality or efficiency of a product or process.
• Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required.
• Research engineering solutions to a diverse set of challenges in production and development.
Supervisory Responsibilities:
• None.
BASIC QUALIFICATIONS | EDUCATION:
• Bachelor's degree (BS) in Engineering or equivalent combination of education and experience.
• Experience working in a GMP, FDA, ISO and USDA regulated environment.
• Knowledge of Database software; AutoCAD Design software; Internet software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.
PREFERRED QUALIFICATIONS:
• Experience with cGMP and ISO 13485 regulations and practices.
• Experience in design/build, automation, PLC programming, equipment troubleshooting.
• Experience with statistical analysis software (Minitab or JMP).

COMPETENCIES:
• Ability to be able to meet deadlines while working on multiple projects.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
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