Job Description
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Catalent, Inc. is a leading global contract development and manufacturing organization dedicated to improving health and wellness. The Computer System Engineer I will support the day-to-day business needs in the laboratory and manufacturing areas by managing computerized systems and ensuring compliance with quality and regulatory standards.
Responsibilities:
- Provides System Administration for various GMP applications including and not limited to network, software, and hardware support and troubleshooting of computerized systems and equipment for Laboratories (Analytics, QC, etc), Manufacturing, and other technology support systems
- Work closely with Catalent Quality, 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 technical IT incidents and determine solutions/workarounds by collaborating with system and/or equipment manufacturers/vendors and applicable 3rd party service providers
- Work closely with Validation and Technology Systems management 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 driven deliverables (Deviations, Follow-Ups, Change Actions, etc.) that relate to hardware, software, and network driven challenges
- Identifies and implements improvement opportunities for Laboratory, Manufacturing and Enterprise computer systems
- All other duties as assigned
Qualifications:
Required:
- Bachelor’s degree in Computer Science (CS), Computer Information Science (CIS), Computer Engineering (CE), Information Technology (IT) or related field
- Knowledge of fundamental IT principles such as TCIP/IP protocol and Active Directory, Data Backups, Data Archival and Disaster Recovery practices; Enterprise Anti-Virus, Firewall, and Cyber Security standards; Application patch management, including System Administration tools; LAN-WAN infrastructure upkeep and operation of computer systems
- Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds
Preferred:
- At least one year technical experience supporting laboratory analytical systems in a GMP environment with strong principles of computer networking, cybersecurity and data integrity
- Experience working with external IT Service providers
- Pharmaceutical and/or Life Science industry experience
Company:
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions. Founded in 2007, the company is headquartered in Somerset, New Jersey, USA, with a team of 10001+ employees. The company is currently Late Stage. Catalent has a track record of offering H1B sponsorships.
Seniority level Seniority level Entry level
Employment type Employment type Full-time
Job function Job function Project Management
Industries Software Development
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Inferred from the description for this job Medical insurance
Vision insurance
401(k)
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Job Tags
Full time, Contract work, H1b,