Computer Systems Engineer I

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 70,000 - 90,000; Full time

Job summary

Catalent is seeking a Computer System Engineer I in Kansas City, MO to support day-to-day laboratory, manufacturing, and related IT needs onsite. You will maintain computerized systems, ensure GMP compliance, and contribute to technology evaluations and strategic IT projects.

The role involves collaborating with Regulatory, Operations and Validation teams to deliver CSV projects, troubleshoot issues, and support audits. 100% onsite, Monday–Friday, 8:00am–5:00pm at our Kansas City site.

Qualifications

• 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.

Responsibilities

• 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, 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.

Skills

System administration

Data integrity

Cybersecurity

GxP compliance

Education

Bachelor's degree in Computer Science/Computer Engineering/Information Technology

Tools

PLC programming languages

Job description

Computer System Engineer I

About Site

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

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 offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

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.