CQV Investigation Lead: Deviation & CAPA Specialist

Veg Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. in Puerto Rico is seeking an experienced CQV Investigation / Deviation Specialist to provide technical investigations during cleaning characterization and sterilization qualification in a GMP biologics environment.

The role involves leading or supporting deviations, reviewing manufacturing records and PI Historian data, and coordinating with Manufacturing, Quality, CQV teams to determine causes.

Qualifications

• Bachelor's degree in Engineering, Science, Biotechnology, Chemistry, Microbiology, or related field.
• Experience supporting investigations in a GMP pharmaceutical or biotechnology manufacturing environment.
• Demonstrated experience with deviations, root-cause analysis, and CAPA.
• Strong understanding of validation and CQV documentation.
• Strong analytical and technical-writing capabilities.
• Ability to work effectively under time-sensitive manufacturing conditions.

Responsibilities

• Lead or support investigations associated with CQV, cleaning characterization, and sterilization activities.
• Perform technical triage of unexpected and non-compliant results.
• Review protocol data, manufacturing records, equipment history, PI Historian data, sampling results, and supporting documentation.
• Conduct structured root-cause investigations.
• Work with Manufacturing, Engineering, Quality, QC, Automation, and CQV teams to determine potential causes.
• Develop technically sound investigation conclusions.
• Own or support QMS deviation records for significant events.
• Identify corrective and preventive actions where appropriate.
• Track investigations and actions through closure.
• Assess potential impact to equipment release, manufacturing activities, and project schedule.
• Provide technical recommendations to project leadership.
• Support preparation of interim summaries and disposition-dependent documentation.
• Maintain investigation documentation in accordance with GMP and client procedures.

Skills

Root-cause analysis

Technical writing

Deviations management

Time management under pressure

Education

Bachelor's degree in Engineering, Science, Biotechnology, Chemistry, Microbiology, or related field

Job description

Validation & Engineering Group, Inc. in Puerto Rico is seeking an experienced CQV Investigation / Deviation Specialist to provide technical investigations during cleaning characterization and sterilization qualification in a GMP biologics environment.

The role involves leading or supporting deviations, reviewing manufacturing records and PI Historian data, and coordinating with Manufacturing, Quality, CQV teams to determine causes.