CSV Manufacturing Consultant (Gap Assessment)

Role & responsibilities

Job Title: CSV Manufacturing Consultant Gap Assessment

Location: Open to Relocation
Employment Type: Full-Time
Department: Manufacturing

Job Summary

We are seeking an experienced CSV Manufacturing Consultant with a strong focus on Gap Assessment, Compliance Evaluation, and Remediation Planning within GxP-regulated pharmaceutical and biotech manufacturing environments. The ideal candidate will possess deep expertise in Computer System Validation (CSV), manufacturing systems, regulatory compliance, system lifecycle management, and validation remediation programs.

This role will be responsible for assessing existing manufacturing and automation systems against current regulatory requirements, industry best practices, and company standards to identify compliance gaps, evaluate risks, and develop remediation strategies. The consultant will work closely with Quality, Manufacturing, Automation, Engineering, and IT teams to ensure systems remain inspection-ready, compliant, and aligned with evolving regulatory expectations.

Preferred candidate profile