Computer Systems Validation Engineer
Core
Identify and implement industry best practices for computer systems validation (CSV) in biotech/pharma manufacturing, ensuring compliance with regulations like 21 CFR Part 11 and GAMP.
Role type
Senior individual contributor Computer Systems Validation Engineer
Builds
Validated computerized systems for biopharmaceutical manufacturing
Domain
Biotechnology / Pharmaceutical Manufacturing / Computer Systems Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer systems validation (CSV), 21 CFR Part 11 compliance, GAMP principles, Change Control processes, Deviation management, CAPA management, Risk assessment, SOP development, Audit participation, DeltaV systems, Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES)
Preferred skills
Project leadership, Mentoring junior staff
Technologies
DeltaV, MES, Distributed Systems, Process Control Systems
Responsibilities
Lead efforts between internal customers and CSV to ensure assigned activities are prioritized, communicated, 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; Perform all aspects of Quality Systems Management (QSM) processes (Change Control, Deviation, Corrective and Preventable Actions) as well as Validation Maintenance of computerized systems; Participate in audits and inspections as a Subject Matter Expert; Own, revise and maintain computer systems validation SOPs; Function as CSV SME in Inspections and Audits; Mentor and train junior members of the department
Seniority
Senior, hands-on IC with mentorship responsibilities
