Bachelors is a hard requirement. Minimum of 5 years’ experience pharmaceutical, medical device, and/or biotechnology industry manufacturing and product software quality engineering and/or assurance experience.
Background in 21 CFR Part 11-compliant software validations, including systems such as inspection systems, vision systems, manufacturing execution systems, and material handling systems
SAP software validation experience (the worker will be validating in SAP)
Knowledge of applicable industry standards, regulations, and requirements (e.g. GAMP, medical device and pharmaceutical GMPs, ISO 9001, ISO 13485, Quality Systems Regulations 21 CFR part 820, EU IVDR and MDR)
Reporting directly to the CLS Transformation Business Advisor, Quality & Regulatory, this position uses industry best practice and quality engineering principles to create and enforce a rigorous software validation program as part of overall product quality architecture commensurate to ever-evolving customer and business needs. This includes, but is not limited to, all stages of product Innovation (& Design/Development Controls) and business/manufacturing/quality software system implementation.
This position works closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement and Business Operations) to develop and implement a standardized, lean, compliant approach to verifying software meets or exceeds internal/external customer and regulatory expectations