Catalent
Drug Development and Delivery
ComputerSystemsEngineer
Neural analysis suggests this role is
optimal for Entry candidates.
“Computer Systems Engineer at Catalent. Skills: Computer System Validation (CSV), Laboratory systems, IT support. Support development, growth, and delivery of computerized systems. Define standard business processes”
Industry & Context.
Problem-solving skills; Analytical skills; Interpret data; Identify trends; Initiate corrective actions; Execute corrective actions; Monitor corrective actions
Ability to perform duties including standing and walking frequently, Sitting continuously, Lifting, pushing, and pulling up to 40 lbs, Occasional kneeling and reaching, Work in a manufacturing environment with exposure to temperature changes, humidity, noise, vibration, wet conditions, and potential hazards, Occasional exposure to extreme heat or cold
What They're Looking For.
Must Have
1 year of hands‑on IT support experience, Bachelor’s degree in Computer Science or equivalent combination of education, certifications, and experience
Nice to Have
Supporting laboratory and analytical systems in a global environment, Microsoft Azure, Active Directory, Windows environments, O365, basic networking concepts
What You'll Do.
and delivery of computerized systems
Define standard business processes
Configure software solutions
Test software solutions
Deploy software solutions
Enhance computer system validation programs
Validate new laboratory computer systems
Validate existing laboratory computer systems
Draft validation protocols
Review validation protocols
Execute validation protocols
Approve validation protocols
Review changes to computerized systems
Approve changes to computerized systems
Monitor computerized systems
Maintain computerized systems
Troubleshoot computerized systems
Respond to audit observations
Implement improvement opportunities
Provide technical assistance
How You'll Work.
Team & Collaboration
Collaborate professionally with supervisors, peers, and cross-functional teams; Work closely with business, consulting partners, and internal IT teams; Act as an expert resource; Assist and manage laboratory system contractors
Communication Scope
Effective written communication skills; Effective verbal communication skills
Process & Methodology
Manage laboratory system contractors
Full Job Description
**Computer Systems Engineer** ** _Position Summary:_** * **Work Schedule: Monday – Friday, 8:00am – 5:00pm** * **100% on-site** Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. The position is responsible for supporting the development, growth and delivery of various computerized systems implemented at the Kansas City Biologics Department. The position will play a key role on the implementation teams that will be responsible for defining standard business processes, configuring/testing/validating the software solutions, and deploying the solutions for the Biologics department. The position works closely with the business, consulting partners, and internal IT teams serving as an expert resource. **The Role:** * Works within the Biologics Validation team in the enhancement of existing computer system validation programs for the validation of new and existing laboratory computer systems, including major capital projects and smaller, stand-alone instrument systems. * Drafts, reviews, executes and approves protocols and reports related to Computer System Validation (CSV). * Acts as a Subject Matter Expert (SME) for Computer System Validation (CSV). * Assists and manages laboratory system contractors as required. * Reviews and approves changes to computerized laboratory systems through the change control program to assess impact on validated software and network systems. * Monitors, maintains and troubleshoots existing computerized laboratory control and monitoring systems.
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