Description

You will manage safety programs and validation processes within pharmaceutical manufacturing environments.

Responsibilities

• Plan, develop, and implement safety programs for pharmaceutical manufacturing processes.
• Prepare plans, templates, and reports for Equipment Validation, Process Validation, Test Method Validation (TMV), and Computer System Validation (CSV).
• Develop PFMEA, CFMEA, BFMEA, Risk Assessment, and Risk Mitigation documentation for implants, non-product software, manufacturing processes, and equipment.
• Perform gap analyses to identify non-compliance with FDA guidance and ISO standards.

Required Skills

• Experience performing PFMEA, CFMEA, and BFMEA.
• Proficiency in Risk Assessment and Risk Mitigation documentation.
• Background as a Validation Engineer or Quality Engineer.
• Knowledge of Equipment Validation, Process Validation, TMV, and CSV.
• Ability to conduct gap analysis against FDA and ISO standards.
• Minimum of 6 months of professional experience in validation or quality engineering.

Preferred Skills

• Master's degree in Pharmaceutical Manufacturing, Engineering, or a related field.

Key Skills

Education

ANY GRADUATE