Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
JOB SUMMARY
Responsible mid-level engineer to support site engineering and technical disciplines that support gene therapy processes which encompass facilities, maintenance, capital projects, validation, and EHS. The right individual for this position must be able to work independently and as a group contributor. This individual must be able to change directions in a fast-paced environment. This person will be responsible for project management, CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization and ensuring all project and day-to-day activities are performed and compliant to all site EHS policies and procedures while maintaining accuracy and quality from conception to completion.
ESSENTIAL JOB FUNCTIONS
SPECIAL WORK REQUIREMENTS
KNOWLEDGE, SKILLS AND EXPERIENCE
EDUCATION/CERTIFCATIONS/LICENSES
BS/BA degree in Engineering, Science, Technical or related field |
Essential |
PMP certification Pharmaceutical, Biomedical, or Medical Device experience |
Desired Desired |
ON-THE-JOB EXPERIENCE
Proven working experience as an Engineer, Project Manager with experience in CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization |
Essential |
Adherence to all local, state, and governmental safety standards |
Essential |
Excellent knowledge of design and visualization software such as AutoCAD |
Essential |
Familiarity with rules, regulations, best practices, and performance standards |
Essential |
SKILLS/ABILITIES
Advanced MS Office skills |
Essential |
Project management and supervision skills |
Essential |
Decision making ability and leadership skills |
Essential |
Time management and organization skills |
Essential |
Ability to work with multiple discipline projects |
Essential |
Work Environment
Movement
Lifting
Vision
Communication
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0 Validation Engineer jobs found in Indianapolis, IN area