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Senior CQV Engineer

4 months ago

Raleigh, United States i-Pharm GxP Full time

Senior CQV Engineer - SME Optima Vial Filling Line (contract)

Summar y This is a subject matter expert (SME) contract role responsible for overseeing the installation, commissioning, qualification, and validation of an Optima washing, filling, and stoppering line for vial filling operations. The Senior CQV Engineer will ensure the line meets all quality, regulatory, and client requirements throughout the installation lifecycle.

Key Responsibilities Act as the technical lead and SME for the Optima vial filling line installation project Generate, review, and approve all associated qualification and validation documentation Oversee equipment installation from landing through Site Acceptance Testing (SAT) Verify installation compliance with standards, workmanship requirements, and client expectations Liaise with equipment manufacturers, Optima engineering teams, and project owners Assist site personnel (tech ops, quality, validation, production, maintenance) in understanding equipment operation Support development of test plans, procedures, and preventative maintenance schedules Collaborate with A&E firms and construction teams to resolve installation issues Ensure critical systems meet all quality and regulatory requirements

Qualificati ons Extensive experience with Optima vial filling equipment installation and validation Comprehensive knowledge of GXP regulations and industry best practices Excellent communication and documentation skills Ability to interface with cross-functional teams at all levels Strong problem-solving and troubleshooting abilities Self-motivated with keen attention to detail Ability to travel to installation site as needed

Education and Experi ence BS degree in Engineering, Science or related technical field 7-10 years of experience in pharmaceutical/biotech equipment validation Prior experience as a CQV SME for aseptic filling lines

heavily preferred

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