Engineer (5-7 years)
Indianapolis, IN 46285 US
• BS in Biological/Chemistry, Engineering, Computer Science related technical fields.• Minimum 3 years of experience in computer system validation for lab analytical instruments. Knowledge of CFR 21 part 11.• Minimum 3 years of experience in a GMP laboratory.• Strong oral and written communication skills
Qualify and validate laboratory analytical instruments, including software installation, configuration, and computer system validation. Provide technical and compliance support to computer systems during the life cycle of the analytical instrument, including but not limited to system administration, periodic reviews, system audit trails, SOP creation. Activities the Computer System Validation Engineer will be responsible for:• Computer system validation and lab instrument qualification• Author computer system validation and lab instrument qualification documents.• Manage System administration and system access.• Communicate with other functions and external vendors regarding qualification and validation issues.• Work with IT infrastructure e.g., define back up strategy.• System administrator duties.• Manage system upgrades.• Execute periodic reviews and system audit trail reviews.• Software configuration and potentially software installation.• Create equipment operation procedures.• Participate in data integrity initiatives related with computer systems. e.g secure desktop installation and configuration.