Engineering CQV SME - Sterilisation / Autoclaves
Core
Senior Engineering CQV Subject Matter Expert specializing in autoclave qualification and equipment temperature mapping for biologics and sterile drug products.
Role type
Senior IC validation engineer (sterilisation/autoclaves)
Builds
Validated autoclave systems and temperature mapping data for Multi-Product Cell Culture and Sterile Drug Product facilities
Domain
Biopharmaceutical manufacturing / Sterilisation science
Required skills
Autoclave commissioning and qualification, Temperature distribution and heat penetration studies, Cycle development and performance qualification, Risk-based validation strategies, Regulatory inspection representation, Technical writing and documentation, Vendor documentation review, Change control and lifecycle requalification, Data integrity and assessment, Mentoring validation professionals
Preferred skills
PhD in Engineering or Life Sciences, Biologics manufacturing experience, Aseptic processing experience, Startup facility experience
Technologies
Thermocouples, Data loggers, Biological indicators, Chemical indicators, Calibration equipment
Responsibilities
Lead complex autoclave commissioning and qualification activities from initiation to closure, Design and execute temperature distribution and heat penetration studies, Develop and optimize autoclave cycles, Author and review qualification plans, protocols, and reports, Act as primary SME during regulatory inspections and audits, Mentor junior and mid-level CQV staff, Collaborate with cross-functional teams to resolve qualification issues
Seniority
Senior, hands-on IC