Validation Engineer

VALIDATION ENGINEER 1

Summary : Under general supervision, reviews specifications and determines the critical aspects

of facilities, utilities, computer systems and manufacturing equipment with regard to product and

process quality, writes qualification protocols for operating systems and records related test

results; prepares final reports that identify the results of protocol testing and the conditions of

release.

Essential Job Functions : This is not intended as a comprehensive list; it is intended to provide

representative summary of the major duties and responsibilities. Incumbent(s) may not be

required to perform all duties listed, and may be required to perform additional, position-specific

tasks.

• Carries out responsibilities in accordance with the organization's policies, procedures,

and state, federal and local laws.

and blue print form, and identifies critical parameters.

and performance of the related facility, utilities, computer systems, or equipment.

validation protocols.

acceptance criterion related to validation and qualification protocols are met.

requirements.

reports as required upon failures to meet protocol acceptance criteria.

procedures.

Performs equipment and system qualification periodic reviews.

Required Knowledge and Skills :

Knowledge of :

and other regulatory requirements.

Skill in :

systems and. construction plans.

where only limited standardization exists.

work.

Physical Requirements and Working Conditions : Incumbents in this class are subject to

extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching

climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up

to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and

dangerous tools and equipment. Work is performed in a manufacturing environment.

Minimum Qualifications : Bachelor's degree in Engineering or a related field from an accredited

college or university and zero (0) to one (1) year of engineering validation experience, preferably

in a pharmaceutical environment, or an equivalent combination of training and experience.