Validation Engineer

Validation & Engineering Group • Raleigh, NC

134d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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).

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.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees