Computer Systems Validation Engineer

Responsibilities

Job Description 

Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.

Work autonomously with related IT contacts and the business process SMEs for this purpose.

Validation documentation preparation (validation plans, user requirements specifications, configuration/design specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports)

Requirements

At least 3 years of experience with CSV remediation.

Bachelor's degree in science, business, or related field.

Proficient in understanding of GxP regulations and validation principles.

Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner.

Mandatory

Tablet press, FBD, Coater, Blender, Granulator, Packaging line, Visual Inspection, SCADA/DCS, FMEA Requirements

Highly self-motivated, self-directed.

Understanding of risk management principles, regulatory requirements and, industry best practices.

Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams.

Role must maintain compliance expertise and be effective at applying requirements in the IT and business environment that supports business goals and maintaining a compliant state