Description

You will manage IT validation packages to ensure they are inspection-ready and compliant with company policies and procedures.

Responsibilities

• Prepare validation documentation including validation plans, user requirements specifications, configuration/design specifications, and risk assessments.
• Execute IQ-OQ-PQ protocols, trace matrices, and summary reports.
• Collaborate autonomously with IT contacts and business process SMEs to maintain a compliant state.
• Provide regulatory guidance and input to project teams to support business goals.

Required Skills

• 3+ years of experience specifically in CSV remediation.
• Hands-on experience with Tablet press, FBD, Coater, Blender, and Granulator.
• Experience with Packaging line, Visual Inspection, and SCADA/DCS systems.
• Proficiency in GxP regulations and validation principles.
• Understanding of risk management principles, regulatory requirements, and industry best practices.
• Ability to apply FMMEA and risk assessment methodologies.
• Bachelor's degree in science, business, or a related field.
• Strong analytical skills for organizing work in a logical and succinct manner.
• Effective written and verbal English communication skills.

Key Skills

Education

Bachelor's degree