Validation Engineer

Aequor TechnologiesDavie, FL, United States

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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.

Reviews electrical, mechanical, and software / computer specifications in manufacturer

and blue print form, and identifies critical parameters.

Writes protocols that challenge the critical parameters related to installation, operation,

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

ssures that protocols are approved through proper channels; writes and revises

validation protocols.

Executes validation and qualification protocols per related SOPs and assures that

acceptance criterion related to validation and qualification protocols are met.

ssures that all test data is gathered and recorded in accordance with cGMP

requirements.

nalyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation

reports as required upon failures to meet protocol acceptance criteria.

Writes final reports and assures that they are approved through proper channels.

Develops and communicates project timelines and status.

Complies with all GMP and safety requirements, SOP's and Company policies and

procedures.

Performs equipment and system qualification periodic reviews.

Performs related duties as assigned.

Required Knowledge and Skills :

Knowledge of :

Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),

and other regulatory requirements.

Pharmaceutical principles, practices and applications.

English usage, spelling, grammar and punctuation.

Principles of mathematical and statistical computations.

Personal computer operations and Microsoft applications (Word, Access, and Excel).

Skill in :

Interpreting software and ladder logic diagrams and flowcharts.

Interpreting electrical, and mechanical blue prints and specifications including HVAC

systems and. construction plans.

Solving practical problems and considering a variety of concrete variables in situations

where only limited standardization exists.

Communicating clearly and concisely, both orally and in writing.

Establishing and maintaining good relationships with those encountered in the course of

work.

Operating a personal computer.

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.

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Validation Engineer • Davie, FL, United States