Description

Lead equipment and system validation activities in a pharmaceutical environment.

This role is on-site.

Responsibilities

• Lead equipment qualification activities including IQ, OQ, and PQ.
• Execute validation protocols for steam sterilizers, autoclaves, lyophilizers, and depyrogenation tunnels.
• Manage deviations by documenting, notifying, and coordinating corrective actions through closure.
• Conduct risk assessments and impact analyses to propose mitigation strategies.
• Act as a Subject Matter Expert during internal and external audits.

Required Skills

• 5+ years of experience in validation or CQV within the pharmaceutical industry.
• Expertise in GMP and Good Documentation Practice (GDP).
• Hands-on experience with V-Model and SDLC methodologies.
• Technical knowledge of steam sterilizers, autoclaves, lyophilizers, and depyrogenation tunnels.
• Experience performing smoke studies and airflow visualization studies.
• Proven ability to manage project work, changes, and CAPAs.

Preferred Skills

• Bachelor's degree or higher in a scientific or engineering discipline.

Key Skills

Education

Any Graduate