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Validation Engineer

ValidationEngineeringGroup · Raleigh, NC
Category Engineering
Posted 10mo ago
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Job description

Company Description Validation & Engineering Group, Inc.  (V&EG) 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. Job Description We are seeking a highly motivated Validation Engineer to support validation activities within regulated industries such as Pharmaceuticals, Biotechnology, Medical Devices, Chemicals, or Food Manufacturing . The Validation Engineer will ensure equipment, systems, and processes meet regulatory requirements and function reliably to maintain product quality and patient safety.

Key Responsibilities

  • Plan, develop, and execute validation protocols (IQ, OQ, PQ) for equipment, utilities, facilities, and manufacturing systems.
  • Support validation of laboratory instruments, production equipment, cleaning processes, and computerized systems.
  • Ensure compliance with cGMP, FDA, EMA, and other applicable regulatory guidelines .
  • Draft and review validation documentation, including protocols, reports, SOPs, and risk assessments.
  • Perform troubleshooting and root cause analysis for validation or equipment-related deviations.
  • Collaborate with cross-functional teams (Engineering, Quality, Manufacturing, Laboratory) to support project deliverables.
  • Participate in change control, CAPA, and continuous improvement initiatives.
  • Maintain accurate records and ensure documentation is audit-ready at all times.

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or related field .
  • 5+ years of experience in validation within pharmaceutical, biotechnology, or related regulated industry.
  • Hands-on experience with validation of manufacturing equipment, laboratory instruments, and/or computerized systems.
  • Strong knowledge of GMP, GLP, and regulatory guidelines .
  • Excellent analytical, organizational, and technical writing skills.
  • Ability to work independently and in cross-functional teams.

Preferred Skills

  • Experience with cleaning validation, sterilization, utilities (HVAC, water, compressed gases) .
  • Familiarity with data integrity and 21 CFR Part 11 compliance .
  • Knowledge of risk-based validation approaches (e.g., ASTM E2500). Additional Information All your information will be kept confidential according to EEO guidelines.