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Validation Engineer
Validation EngineerQRC Group, Inc • Raleigh, NC, US
Validation Engineer

Validation Engineer

QRC Group, Inc • Raleigh, NC, US
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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 : 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.

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    Validation Engineer • Raleigh, NC, US

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