Equipment Validation Engineer

Position- Equipment Validation Engineer
Location- North Carolina
Experience- 7+ years

Industry- Pharma

Job Summary:
We are seeking an experienced Equipment Validation Engineer with a strong background in the pharmaceutical industry. The ideal candidate will have at least 7 years of hands-on experience in equipment qualification and validation, with specific expertise in incubators, isolators, autoclaves, and other GMP-regulated systems.

Key Responsibilities:
Plan, execute, and document equipment qualification and validation activities (IQ/OQ/PQ) in compliance with GMP, FDA, and internal quality standards.

Lead validation projects for equipment such as incubators, isolators, autoclaves, and controlled temperature units.

Prepare and review validation protocols, risk assessments, and summary reports.

Coordinate with cross-functional teams including Quality, Engineering, and Manufacturing.

Support deviation investigations, CAPAs, and change controls related to equipment.

Ensure timely execution of validation tasks and accurate documentation.

Stay current with industry trends and regulatory expectations.

Required Skills & Qualifications:
Bachelor s or Master s degree in Engineering, Life Sciences, or a related field.

Minimum 7 years of experience in equipment validation in a GMP pharmaceutical environment.

Proven expertise in validation of incubators, isolators, autoclaves, and related cleanroom equipment.

Strong understanding of FDA, EMA, and ICH guidelines.

Excellent documentation, communication, and project management skills.

Ability to work independently and as part of a team in a fast-paced environment.

Preferred Qualifications:
Experience with computerized systems validation (CSV) is a plus.

Knowledge of aseptic processing and cleanroom classifications.

Familiarity with validation software and tools.