CQV Investigation / Deviation 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

Current job opportunities are posted here as they become available.

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position.

Job Summary:
We are seeking an experienced CQV Investigation / Deviation Specialist to provide technical investigation support during cleaning characterization and sterilization qualification activities in a GMP biologics manufacturing environment.

The role will support rapid triage and investigation of deviations, discrepancies, unexpected results, and other events generated during protocol execution.

Key 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.

Required 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.

Preferred Qualifications

• Experience with biologics drug-substance operations.
• Experience reviewing PI Historian/process data.
• Previous Amgen Quality, Verification, or manufacturing experience.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.