Job: Validation Engineer - Quality

Jobing Description

This is for the 1st Shift

Under general direction, provide direct technical validation support for cleaning and steaming processes and/or equipment upgrades, replacements, and modifications in manufacturing, manufacturing support or the laboratory environment.

Develop solutions to technical validation issues of moderate complexity, interprets generally defined practices and procedures, may set project timelines and priorities based on validation project objectives, as well as understand and apply principles and standards to the implementation of equipment or process modifications.

Develop solutions to technical validation problems, identifying and escalating complex technical issues, providing support to investigations, independently executing protocols, evaluates data, and performs assignments that have defined objectives.

Execute policies/procedures and work with validation engineers on an ongoing project basis, become actively involved in daily operations when required to meet schedules or to resolve validation issues, and routinely audit the validation status and regulatory compliance of a large number of highly complex equipment items or systems.

Lead efforts with manufacturing, engineering, process development, labs, and/or quality assurance in developing requirements and recommendations for system modifications. Basic Qualifications Master s degree

OR

Bachelor s degree and 2 years of directly related experience

OR

Associate s degree and 6 years of directly related experience

OR

High school diploma / GED and 8 years of directly related experience
Preferred Qualifications Basic knowledge in equipment, facility, cleaning and steaming validation

Technical understanding of pharmaceutical/biotechnology unit operations

Project management skills

Database and spreadsheet application skills

technical writing and oral communication skills

Facilitation and presentation skills