Engineer (5-7 years)
Indianapolis, IN
Experience: 0
Category: Engineering
Brand: Joule
Job ID: 298105
Date Posted: 03/17/2023
Shortcut: http://jobs.systemoneservices.com/pgCrM8
Engineer, Computer System Validation
Must Haves:
• 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
Responsibilities:
• 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.
Duration: 8 months
Shift: M-F, 8-5
Location: Indianapolis, IN 46285
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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