Computer Systems Engineer I

Catalent; Kansas City (MO); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Competitive paid time off

Paid holidays

Job summary

Catalent's Kansas City facility is seeking a Computer Systems Engineer I to maintain computerized and equipment systems, ensure regulatory compliance, and support IT/CSV tasks in a GMP environment.

The role involves collaboration with Regulatory, Operations and Validation, on-site work in Kansas City, and opportunities for growth within a diverse team.

Qualifications

• Bachelor's degree in Computer Science, Computer Engineering or related field.
• 1+ years of technical experience supporting laboratory analytical systems in a GMP environment.
• Strong networking, cybersecurity and data integrity fundamentals.

Responsibilities

• Provide system administration for network, software, and hardware support in maintaining and troubleshooting computerized laboratory, enterprise, production, and technology support systems.
• Deliver Computer System Validation (CSV) projects and support tasks involving integration and implementation of existing, upgraded and new systems, equipment, instruments and applications following GxP guidelines.
• Troubleshoot problems and determine solutions and workarounds; collaborate with vendors and all appropriate parties to resolve issues.
• Work closely with CSE II associate and/or Senior staff to manage scope, schedule, and budgets for technology projects.
• Assist in responding to customer/regulatory audit observations and corrective actions related to computer system implementation, validation, maintenance, and administration.

Skills

System administration

GxP compliance

Data integrity

Troubleshooting

Regulatory collaboration

Education

Bachelor's Degree in Computer Science

Tools

Networking hardware

CSV tools

IT networking

Job description

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Computer System Engineer I

Position Summary

We have an opportunity for a Computer Systems Engineer I to join our team. In this role, you will support day-to-day business needs in laboratory, manufacturing, and related areas by maintaining computerized and equipment systems at the Kansas City site. You will ensure regulatory compliance through IT, compliance, and Good Manufacturing Practices skills, focusing on system administration, data integrity, and troubleshooting. You will also participate in technology evaluations, implementations, and strategic IT projects.

Shift: Monday- Friday; 8:00am-5:00pm

Location: Kansas City, MO

100% Onsite

The Role

• Provides system administration for network, software, and hardware support in maintaining and troubleshooting computerized laboratory, enterprise, production, and technology support systems.
• Work closely with Catalent Regulatory, Operations, and Validation to deliver Computer System Validation (CSV) projects and support tasks involving integration and implementation of existing, upgraded and new systems, equipment, instruments and applications following GxP guidelines.
• Troubleshoot problems and determine solutions and workarounds. Collaborates with vendors and all appropriate parties to resolve issues.
• Work closely with CSE II associate and/or Senior staff to manage up to pre-defined scope, schedule, and budgets for technology projects; by means of working both independently and as a member of a project execution team.
• Assists in responding to customer / regulatory audit observations and corrective actions as it pertains to computer system implementation, validation, maintenance, and administration.
• Provide technical input required to complete Quality Assurance driven deliverables (investigations, Complaints, Deviations, etc.) that relate to hardware, software, and network driven challenges.
• Identifies and implements improvement opportunities for established laboratory and production computer systems.
• Keeping abreast of technology developments with a working knowledge of multiple computer/PLC programming languages and IT networking architectures
• Provides technical assistance. training for personnel (as needed) and other duties as assigned
• All other duties as assigned.

The Candidate

• Bachelor's Degree in Computer Science, Computer Engineering, Information Technology or related field
• 1+ years technical experience supporting laboratory analytical systems in a GMP environment with strong principles of computer networking, cybersecurity and data integrity are preferred.

Preferred Skills & Background

• Experience working with external IT service providers.
• Pharmaceutical and/or life science industry experience preferred but not required.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.