Chemistry Engineer

Chemistry Engineer needs 3 years of experience in a GMP laboratory.

Chemistry Engineer requires:

• 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.
• Computer system validation and lab instrument qualification
• Minimum 3 years of experience in a GMP laboratory.
• Strong oral and written communication skills

Chemistry Engineer duties:

• 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.
• 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.
• 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.

Remote Work :

No