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Validation Engineer
2 months ago
Validation Engineer
Location: Davie, FL
Essential Areas of Responsibility
Reviews electrical, mechanical, and software/computer specifications in manufacturer and blue print form, and identifies critical parameters.
Writes protocols (IQ/OQ/PQ) that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
Assures 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.
Assures that all test data is gathered and recorded in accordance with cGMP requirements.
Writes final reports and assures that they are approved through proper channels.ps and communicates
Complies with all GMP and safety requirements, SOP’s and Company policies and procedures.
Performs related duties as assigned.
Performs periodic reviews of equipment and system qualifications, prepares summary report, and assigns CAPAs to address deficiencies. Includes reviews of change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS as applicable.
Education/Certification/Experience:
Technical knowledge of computerized system/equipment preferably oral dosage manuf., facilities and utilities;
Familiar with GAMP, CFRPart11 requirements,
Good oral and written communications in English
Works independently with minimal supervision
Able to write protocol deviations and identify root cause and corrective actions
Master’s or Ph.D. in Science, Engineering or pharmacy required (Chemical, biomedical or Mechanical preferred)
2-5 years of experience within pharmaceutical or related manufacturing facility
Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.
Experience in development and execution of qualification protocol/reports as related to automated equipment/systems preferred.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
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