CQV Validation Engineer

Shoolin Inc; North Carolina; On-site; USD 75,000 - 100,000; Full time

Job summary

Shoolin Inc is seeking a CQV Validation Engineer in North Carolina. The role involves executing commissioning and qualification activities, developing validation protocols, and ensuring compliance with regulatory standards. Candidates should have 3-5 years of experience in the pharmaceutical or biotech industries and knowledge of GMP, FDA regulations, and validation lifecycle documentation. Strong communication skills and a Bachelor's degree in a relevant field are preferred. This position promises a rewarding opportunity in a dynamic environment.

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.

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.

Skills

CQV / Validation experience

IQ, OQ, PQ protocols

Documentation skills

Cross-functional communication

Knowledge of GMP, GDP, FDA regulations

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Job description

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