Validation Engineer

Guidance of validation / qualification projects in accordance with GMP rules by developing / reviewing instructions related to manufacturing process validation / cleaning validation / packaging process qualification; conducting scheduled periodic assessments of manufacturing process validation status and providing data for the formation of Product Dossiers; development of manufacturing process validation plans and reports; development of packaging process qualification plans and reports; development of material shelf-life stability plans and reports; development of cleaning validation plans and reports; expert assessment of planned changes within the Change control procedure; participation in self-inspections; expert assessment of deviations from a validation perspective; participation in the preparation for the implementation of new products and transfers; substitution for the Validation Engineer and partial substitution for the Head of Validation Department.

Requirements

At least 2 years of experience in similar positions. Knowledge of EAEU and EU GMP sections related to equipment and systems qualification; manufacturing and packaging process validation; cleaning validation. Knowledge of solid dosage form manufacturing technology (critical stages / equipment parameters). Knowledge of statistics fundamentals. English language proficiency at least at B1 level for writing documentation and reading regulatory documents. Skills in developing validation / qualification instructions. Skills in using statistical data processing software.

Higher education — Bachelor's degree; Experience: 2 years

Conditions

Allowable