Senior Validation Engineer
Core
Oversee validation strategies and documents for Finished Drug Product (FDP) qualifications (OQ, PQ, PPQ) at contract manufacturing organizations (CMOs) in the JAPAC region, ensuring high-quality product supply for patients.
Role type
Senior Validation Engineer (Pharmaceutical Manufacturing)
Builds
High-quality pharmaceutical products and packaging processes at CMOs
Domain
Biotechnology / Pharmaceutical Manufacturing / Quality Assurance
Required skills
Process validation, packaging process qualification, statistical sampling plans, risk-based decision making, synthetic API manufacturing validation, aseptic processing oversight, regulatory compliance (cGMP), change control assessment, deviation review, Master Batch Record approval, marketing application validation sections
Preferred skills
Biologic drug substance validation, cleaning validation, aseptic process simulation, complex deviation resolution, process design at conceptual level, audit/inspection preparation (via careerplan.io/jobs/R-227587-senior-validation-engineer-at-amgen)
Technologies
OQ, PQ, PPQ, cGMP, Master Batch Records, Media Fill, Autoclave validation, EM (Environmental Monitoring)
Responsibilities
Lead validation for new product introductions and tech transfers, translate Amgen requirements into CMO language, assess validation/quality risks, author and approve validation documents, oversee packaging and device qualifications, determine sample plans and acceptance criteria, oversee synthetic API and cleaning validations, manage aseptic processing systems, prepare audit materials, perform change control assessments, review deviations and batch records, author validation sections for regulatory submissions
Seniority
Senior, hands-on IC
