Principal/Senior Principal, Quality Engineer Validation
Core
Apply validation principles and quality systems to oversee equipment, facility, utility, and manufacturing processes for drug product production.
Role type
Principal/Senior Principal Quality Engineer Validation
Builds
Reliable delivery of Roche's commercial portfolio and pipeline products
Domain
Pharmaceutical manufacturing (drug product & finished goods)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations, industry standards, tech transfer oversight, new facility expansions, large construction projects, scale up/adoption of digital technology
Preferred skills
single-use autoinjector platforms experience
Responsibilities
review and approve qualification and validation documents, perform quality oversight of equipment and facility systems, oversee tech transfer and facility expansions, solve complex cross-functional problems using analytical thinking
Seniority
Principal (8+ years) / Senior Principal (12+ years), expert level
