Job Title: CQV Validation Engineer

Location: North Carolina (Onsite)

Employment Type: Contract

Overview:

Seeking a CQV Validation Engineer with experience in commissioning, qualification, and validation activities within pharmaceutical, biotech, or medical device environments. The role involves equipment qualification, validation documentation, and ensuring compliance with GMP and regulatory standards.

Required Qualifications:

• 3-5 years of CQV / Validation experience in pharma, biotech, or life sciences industry
• Strong knowledge of IQ, OQ, PQ protocols and execution
• Experience with equipment, utility, facility, and process validation
• Knowledge of GMP, GDP, FDA regulations, and GAMP 5
• Experience in validation lifecycle documentation, deviations, CAPA, and change control
• Familiarity with SOPs, risk assessments, and commissioning activities
• Strong documentation and cross-functional communication skills

Key Responsibilities:

• Execute commissioning and qualification activities for equipment and systems
• Develop and review validation protocols and reports
• Support deviation investigations, CAPA, and change controls
• Ensure compliance with regulatory and quality standards
• Coordinate with engineering, QA, manufacturing, and validation teams

Preferred Qualifications:

• Experience with manufacturing systems, utilities, or cleanroom validation
• Bachelor’s degree in Engineering, Life Sciences, or related field