Process Validation Engineer
Core
Execute process validation protocols and regulatory documentation for drug substance manufacturing to ensure cGMP compliance and support product lifecycle activities.
Role type
Process Validation Engineer (Manufacturing Sciences)
Builds
Validated manufacturing processes for commercial and pipeline biopharmaceutical products
Domain
Biopharmaceutical manufacturing / Process Engineering
Required skills
Process validation methodologies, Technical writing, Regulatory submission support, Quality Systems (cGMP), Data integrity verification, Root-cause analysis, CAPA implementation, Equipment qualification, Cleaning validation
Preferred skills
Electronic document management systems (Veeva, Smartsheet), Cleanroom gowning procedures
Technologies
Veeva, Smartsheet, AppSheet, PPQ OneDoc, PAS, IMA
Responsibilities
Author and execute PV protocols and regulatory deliverables, Perform compliance and data-integrity checks on validation documents, Maintain master schedule and track project milestones, Support product introductions and process transfers, Facilitate cross-functional review workflows, Assist with root-cause investigations and CAPA design
Seniority
Mid-level, hands-on IC