| CSV Engineer-IN-onsite at Indianapolis, Indiana, USA |
| Email: [email protected] |
| From: sravani, Nitya INC [email protected] Reply to: [email protected] Computer System Validation Engineer with Lab instruments Job Function: CSV Engineer Job Type: 1 year Contract Location: Indianapolis, IN Please forward me Your TOP candidates resume with rate and contact number. ( Send me only 1 resume) Scope of Job RCM is seeking a CSV Engineer for our biotechnology client. This is a great opportunity with an industry leader. The right candidate will qualify and validate laboratory analytical instruments, including software installation, configuration, and computer systems 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. Primary Responsibilities Computer System Validation and lab instrument qualification Author computer system validation and lab instrument qualification documents, including define test cases and write and execute test scripts. 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 backup 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 to computer systems, secure desktop installation and configuration. Qualifications Minimum 5 years of experience in Computer System Validation for Lab Analytical Instruments Knowledge of CFR 21 part 11 Experience in GMP Laboratory and Data Integrity ALCOA + Principles. Knowledge of GMARS Knowledge of Trackwise Knowledge of Kneat Excellent communication skills, both verbal and written, good communicator Great Interpersonal Skills Excellent organizational skills and attention to detail and accuracy Education & Certifications BS in Biological/Chemistry, Engineering, Computer Science related. Keywords: information technology |
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| Sat Feb 17 02:39:00 UTC 2024 |