Senior QA Validation Specialist — GMP & Automation

Regeneron Pharmaceuticals, Inc.; Saratoga Springs (UT); Presencial; USD 92.000 - 176.000; Tempo integral

Resumo da vaga

Regeneron Pharmaceuticals is seeking QA Validation Specialists for our Saratoga Springs, NY facility. You will validate and qualify laboratory and analytical equipment (HPLC, GC, balances, spectrophotometers, incubators) to GMP standards, with optional leadership responsibilities in the future.

The role entails analyzing results, addressing deviations, and coordinating with QC, Manufacturing Science, and external vendors in a highly automated, digitally integrated environment.

Qualificações

• Experience with laboratory or analytical instrumentation in a GMP environment.
• Previous people leadership/supervisory experience preferred.

Responsabilidades

• Generates, executes, and reviews qualification and validation protocols, summaries, and data for lab/analytical equipment.
• Analyzes testing results and determines acceptability against criteria.
• Investigates problems with lab equipment and recommends solutions.
• Reviews deviation notifications, investigations, and corrective actions.
• Reviews change controls, SOPs, reports and other docs.
• Provides secondary support for qualification of manufacturing equipment and utilities.
• Coordinates validation tasks with Quality Control, Manufacturing Science, and external vendors.
• Trains and mentors teammates; may manage staff and contractors.
• Manages projects and prepares status reports.
• Other duties as assigned.

Conhecimentos

Laboratory instrumentation GMP

Leadership experience

Formação

BS/BA in Engineering, Chemistry, or Life Sciences

Descrição da vaga

Regeneron Pharmaceuticals is seeking QA Validation Specialists for our Saratoga Springs, NY facility. You will validate and qualify laboratory and analytical equipment (HPLC, GC, balances, spectrophotometers, incubators) to GMP standards, with optional leadership responsibilities in the future.

The role entails analyzing results, addressing deviations, and coordinating with QC, Manufacturing Science, and external vendors in a highly automated, digitally integrated environment.