CQV Specialist I

Responsibilities

• Execute commissioning, qualification, requalification, and validation activities for facilities, equipment, utilities, and computerized systems
• Author, execute, and review CQV protocols, reports, and validation documentation
• Support investigations, deviations, CAPAs, change controls, and remediation activities
• Participate in risk assessments, FMEAs, periodic qualifications, and validation master plans
• Cookordination with engineering, manufacturing, quality, and external vendors to support multiple CQV projects
• Ensure validation activities are performed in accordance with cGMP requirements and data integrity standards

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
• 2-4+ years of CQV, validation, or engineering experience in a GMP pharmaceutical or biotechnology environment
• Experience authoring and executing validation documentation
• Strong knowledge of cGMP regulations and validation lifecycle activities
• Experience with change controls, deviations, CAPAs, and risk assessments
• Familiarity with 21 CFR Parts 210, 211, and 1271
• Experience with TrackWise, Maximo, CMMS, or similar systems is a plus
• Strong communication and organizational skills with the ability to manage multiple priorities