Job Description
Act as the primary CQV SME during pre-sales discussions with pharma/biotech clients Identify new qualification/validation opportunities across labs, manufacturing, QC, and QC IT landscapes Identify opportunities in facility, utilities, and equipment qualification projects including cleanrooms, HVAC, compressed gases, water systems (PW/WFI), autoclaves, incubators, and environmental monitoring systems Develop solutions and effort models for FAT/SAT support, commissioning, IQ/OQ/PQ, and performance verification of critical utilities. Lead requirement discovery sessions, customer workshops, and technical deep-dive meetings Build trusted advisor relationships with client stakeholders Engage early with prospects to qualify opportunities, discover needs, and shape CQV solution approaches (ASTM E2500, ISPE Baseline Guides, GAMP 5 2nd Ed., ICH Q9/Q10) Architect delivery models (onsite/offshore/hybrid), timelines, governance, and staffing plans