Computer Systems Validation Lead Engineer - Lonza America : Job Details

The focus of the Computer Systems Validation (CSV)Lead Engineer role is to identify or create industry best practices and implement these within the framework of existing GAMP regulations. Responsibilities of the CSV Lead Engineer will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions as well as ownership of department procedures. The position provides guidance to junior team members. Key Responsibilities:Lead efforts between internal customers and CSV to ensure assigned activities are prioritized, communicated in an effective and timely manner, and completed on time. Accountable for maintaining full knowledge of Lonza's policies/procedures, 21 CFR Part 11, Data Integrity, ICH Q 7 A requirements and GAMP and the underlying principles of each. Perform all aspects of QMS processes (Change Control, Deviation, CAPA) as well as Validation Maintenance of computerized systems. Participate in ...Computer, Systems, Validation, Lead, Engineer, Manufacturing, Technology