Validation Engineer

Job Description:
We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation
skills.

This role is critical in ensuring compliance, validation, and
accurate documentation of enterprise applications, particularly in regulated
environments (GxP/ CFR Part ).
Responsibilities:

Perform Computer System Validation (CSV) activities for SAP and OpenText systems.

Develop and execute validation protocols (IQ, OQ, PQ) in line with industry regulations.

Ensure compliance with FDA, GxP, and CFR Part requirements.

Collaborate with IT, QA, and business stakeholders to gather requirements and translate them into validation deliverables.

Author, review, and maintain validation documentation, technical specifications, and SOPs.

Provide technical writing support, including preparation of user guides, technical documentation, and audit-ready records.

Support audits and inspections by providing validation evidence and documentation.