Computer System Engineer

Catalent Pharma Solutions • Kansas City, MO

2d • Onsite

About The Position

Computer Systems Engineer Position Summary: Full time salaried position Onsite based out of our Kansas City, MO location The Computer Systems Engineer is responsible for supporting the development, growth and delivery of various computerized systems implemented at the Kansas City Biologics Department. The Computer Systems Engineer 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. Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. 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 Assists in responding to customer / regulatory audit observations and corrective actions as it pertains to computer system implementation/validation Identifies and implements improvement opportunities for established laboratory computer systems Other duties as assigned

Requirements

• High School diploma with a minimum of seven years experience within IT support, required
• Microsoft Azure, Active Directory, Windows, O365, basic networking, required

Nice To Haves

• Associates degree with a minimum of four years experience within IT support, preferred
• Bachelor’s Degree in Computer Science with a minimum of two years experience within IT support, preferred
• Experience supporting laboratory and analytical systems in a global environment, preferred

Responsibilities

• 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
• Assists in responding to customer / regulatory audit observations and corrective actions as it pertains to computer system implementation/validation
• Identifies and implements improvement opportunities for established laboratory computer systems
• Other duties as assigned

Benefits

• Defined career path and annual performance review and feedback process
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• WellHub - program to promote overall physical wellness

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED