Senior CQV Validation Engineer - Onsite Puerto Rico SMVP

ProQuality Network; United States; Hybrid; USD 120,000 - 170,000; Full time

Job summary

ProQuality Network in the United States is seeking an experienced CQV Validation Consultant to support assessment, remediation, and updates of Site Master Validation Plans within a regulated pharmaceutical manufacturing environment.

The ideal candidate will have extensive CQV expertise, strong technical writing, and deep knowledge of validation lifecycle governance, change control, and maintenance programs, with responsibilities spanning gaps, documentation updates, and executive communications.

Qualifications

• Bachelor's degree in engineering, life sciences, pharmacy, biotechnology or related technical discipline.
• Extensive CQV experience in regulated pharmaceutical/biotechnology environments.
• Strong knowledge of validation lifecycle governance and change control processes.
• Proven ability to assess, remediate and align validation documentation and quality systems.
• Excellent analytical, organizational, and communication skills for senior leadership interactions.

Responsibilities

• Review Site Master Validation Plans (SMVP) for multiple buildings and assess structure, readability and alignment with SOPs and standards.
• Identify gaps, missing records, outdated references, and opportunities for compliance improvements.
• Update SMVP documentation to reflect current validated state and lifecycle oversight.
• Prepare gap assessment summaries and executive-level presentations; ensure inspection-ready documentation.
• Serve as primary contact for SMVP initiative and coordinate across QA, Manufacturing, and governance forums.

Skills

CQV experience

cGMP

Validation lifecycle governance

Change control

Validation maintenance

Document remediation

Regulatory compliance

Technical writing

Leadership communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Job description

ProQuality Network in the United States is seeking an experienced CQV Validation Consultant to support assessment, remediation, and updates of Site Master Validation Plans within a regulated pharmaceutical manufacturing environment.

The ideal candidate will have extensive CQV expertise, strong technical writing, and deep knowledge of validation lifecycle governance, change control, and maintenance programs, with responsibilities spanning gaps, documentation updates, and executive communications.