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Validation Specialist

Medical Devices & Pharmaceuticals Mfg
Dallas, Texas, United States
$85-100K + Bonus
February 08, 2017

Validation Specialist - $85-100K + 10% Bonus – Medical Devices & Pharmaceuticals Mfg - Collaborates with departments, outside contractors, and suppliers to ensure projects are successfully completed on time and on budget. Prepares project timeline and milestone dates; monitors project progress against the timelines and plans corrective actions if needed. Provides project status reports to appropriate managers to ensure visibility of project status. Manages technology transfer activities for new products and processes to the facility. Manages technology transfer activities from providing Clinical Trial Supplies to Process Scale Up and Validation to PAI inspection and ultimately commercialization of products. Provides technical expertise for new products and processes for the facility. Works with all departments to optimize manufacturing processes. Works with suppliers to detail mechanical specifications for processing equipment. Prepares Request for Proposals, Technical Specifications and other documentation to ensure project results are ultimately achieved. Prepares Capital Expenditure requests required for projects and manages project spending.

Provides technical guidance and team developer leadership.

Bachelor’s degree in Biological Sciences, Chemistry or Engineering - Two (2) years of experience in Validations – STERILIZATION EXPERIENCE REQUIRED! - Proficient in Microsoft Office is required including MS Project - Two (2) years of project management experience leading projects with multi-disciplinary teams - Three (3) years’ experience in the Pharmaceutical and/or Medical Device industry, or equivalent experience. Experience working in a GMP regulated environment preferred. Must have FDA Regulated like Pharma or Medical Device or other. Sterile IQ/OQ/PQ helpful – Manufacturing only, NOT COMPUTER VALIDATION TYPES. Experience in Project Management of projects of a technical nature. Experience in the manufacturing of pharmaceutical with knowledge of the validation water systems, clean rooms, aseptic processing operations, sterilization, analytical methods, equipment and computer systems. Knowledge of aseptic processes. Knowledge of FDA regulated industrial environment