Impactful CQV Validation Engineer (Pharma/Biotech)

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

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.