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 Q7A 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 audits and inspections as a Subject Matter Expert. Own, revise and maintain CSV SOPs. Supports all activities associated with qualification and the required documentation for CSV Validation while assuring adherence to regulatory guidelines. Acts as point person for customer communications as assigned and assists other team members in customer communications. Develop complex CSV Val protocols for execution including Interface Qaul, and for PCS/MES system. Mentor and train junior members of the department. Assess gaps in CSV program compliance and Data Integrity program, and establish remediation plans for the gap remediation. Support operational phase maintenance from a validation standpoint of newly implemented computerized systems. Execute all duties as assigned. Key Requirements: Bachelor’s Degree is required (preferably in Computer Science/Software Engineering). 5-10 years’ of Computer Systems Validation experience. Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation. Strong written and oral communication skills. Strong organizational and time management skills.
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