Engineer, Computer Software Assurance
Core
Ensuring computerized systems used in GxP processes comply with global regulatory requirements and providing strategic oversight of CSV activities.
Role type
Senior Computer Software Assurance Engineer (Regulatory Compliance)
Builds
Validated GxP-regulated computerized systems including ERP, QMS, MES, manufacturing equipment software, and custom applications.
Domain
Medical device / Life sciences / Regulatory compliance
Required skills
Computer System Validation (CSV) strategy, IQ/OQ/PQ execution, 21 CFR Part 11, 21 CFR Part 820, ISO 13485, GAMP5, data integrity, audit trails, validation documentation (URS, traceability matrix, summary reports)
Preferred skills
EU MDR, Annex 11, ISO 27001, cloud-based/SaaS validation, FDA/Notified Body inspection support, CSV/QMS process enhancement
Technologies
ERP, QMS, MES, manufacturing equipment software, cloud-based systems, SaaS
Responsibilities
Lead and execute comprehensive CSV strategies and protocols; Oversee validation activities for GxP-regulated systems; Ensure systems meet FDA and ISO requirements for software validation and electronic records.
Seniority
Senior, strategic oversight and execution