Description

You will manage the commissioning and qualification lifecycle for GMP utilities, facilities, and process equipment.

Responsibilities

• Plan and track implementation of commissioning and qualification actions against project timelines.
• Author, execute, and evaluate DQ, IQ, OQ, FT, and PQ protocols and final reports.
• Investigate protocol discrepancies and implement corrective actions for new or modified equipment.
• Prepare and approve technical documentation including URS, FMMEA, risk assessments, and master plans.
• Coordinate FAT/SAT and commissioning activities with internal and external partners.

Required Skills

• 5+ years of experience in a C&Q/CQV role within a pharmaceutical organization.
• Degree in a technical or natural scientific field.
• Direct experience with cGMP guidelines and quality assurance principles.
• Proficiency with Kneat Gx or similar digital C&Q systems.
• Ability to manage multiple projects in parallel and work with cross-department stakeholders.
• Strong analytical thinking and technical writing skills.
• Knowledge of cGMP documentation standards.

Preferred Skills

• Prior involvement with ISPE baseline guides Volume 3, Volume 4, and Volume 5.

Key Skills

Education

Any Graduate