Validation & Engineering Group, Inc. · 17 hours ago
ATL01-020426 Investigation and CAPA Specialist
Duluth, GA
Contract
Onsite
Senior Level
5+ years expValidation & Engineering Group, Inc. is a trusted consulting partner to regulated life sciences companies, providing expertise across every stage of the product lifecycle. They are seeking experienced Investigation and CAPA Specialists to provide on-site support for deviation investigations, root cause analysis, and CAPA development within a regulated aseptic manufacturing environment.
BiotechnologyConsultingProfessional ServicesQuality Assurance
Responsibilities
Lead and support manufacturing-driven investigations from initiation through completion, in alignment with site procedures and cGMP expectations
Perform detailed reviews of manufacturing processes, batch records, and supporting data to support root cause determination
Conduct interviews with manufacturing, operations, and support personnel
Author clear, concise investigation documentation, including root cause analysis and recommended CAPAs, for Quality review and approval
Support development, tracking, and closure of CAPAs, including effectiveness checks as applicable
Support ongoing and new investigations while maintaining on-site presence in manufacturing areas as required
Interface effectively with Manufacturing, Engineering, Training, and Quality functions
Ensure investigation documentation is accurate, complete, and inspection-ready
Qualification
Required
Bachelor's degree in Engineering, Science, or a related technical discipline (or equivalent industry experience)
Minimum of 5 years of experience supporting investigations in pharmaceutical or biotechnology manufacturing
Demonstrated experience leading manufacturing or process investigations and authoring investigation reports
Strong technical writing skills and ability to clearly document complex investigations
Understanding of aseptic manufacturing processes and cGMP requirements
Experience gathering data, conducting interviews, and supporting root cause analysis
Ability to manage multiple active investigations concurrently
Preferred
Knowledge of gowning practices and aseptic monitoring controls
Company
Validation & Engineering Group, Inc.
Validation & Engineering Group, Proudly serving our clients since 1997.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2025-08-06Acquired
Leadership Team
Luis Puig
Partner
Recent News
News is my Business
2025-08-20
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