Validation Engineer

Job Title: Validation Engineer

Location: Concord, NC

Duration: Long Term

Job Summary

We are seeking a motivated and detail-oriented Validation Engineer to support validation activities within a GMP-regulated biopharmaceutical manufacturing environment. The Validation Engineer will be responsible for equipment qualification, process validation, utility validation, and cleaning validation activities to ensure compliance with FDA, cGMP, and industry standards.

The ideal candidate will collaborate with Manufacturing, Quality Assurance, Engineering, and Regulatory teams to support production operations, maintain validated systems, and ensure regulatory compliance across the facility.

Key Responsibilities

Develop, execute, and review validation protocols and reports including IQ, OQ, and PQ documentation
Support equipment qualification activities for biopharmaceutical manufacturing equipment and laboratory systems
Perform process validation for upstream and downstream manufacturing processes
Execute cleaning validation and utility qualification activities including HVAC, purified water, compressed gases, and cleanroom systems
Ensure compliance with FDA, cGMP, GDP, and company quality standards
Support computerized systems validation (CSV) activities when required
Participate in deviation investigations, root cause analysis, CAPA, and change control processes
Collaborate with cross-functional teams during equipment installation, commissioning, and technology transfer projects
Maintain validation lifecycle documentation including SOPs, Validation Master Plans (VMP), and risk assessments
Assist during internal audits and regulatory inspections by providing validation documentation and technical support
Identify and implement continuous improvement opportunities within validation and manufacturing processes

Required Qualifications

Bachelor s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Biotechnology, or related field
3+ years of validation experience in biopharmaceutical, pharmaceutical, or regulated manufacturing industries
Strong understanding of cGMP, FDA regulations, and validation principles
Experience with IQ/OQ/PQ protocol execution and report generation
Knowledge of process validation, cleaning validation, and utility qualification
Familiarity with deviation management, CAPA, and change control systems
Strong technical writing and documentation skills
Excellent communication, analytical, and problem-solving abilities
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