CSV Technical Engineer

Coral Springs, FL, US • Posted 30+ days ago • Updated 10 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Technical Support
Technical Drafting
Manufacturing Support
Regulatory Compliance
Provisioning
ROOT
Recovery
Technical Writing
Account Management
Backup & Restore
Auditing
Backup Administration
Disaster Recovery
Testing
Quality Management
QMS
Security Controls
Servers
Hosting
Endpoint Protection
Hardening
Cyber Security
Computer Hardware
Quality Assurance
Computerized System Validation
Information Technology
Computer Science
System Administration
Pharmaceutics
Collaboration
GxP
Data Integrity
GAMP
Documentation
Management

Summary

Job Summary:

The GxP IT Systems Support / CSV Technical Contractor provides hands-on IT support for computerized systems used in GxP operations at the Coral Springs site.
This role focuses on system administration, technical troubleshooting (including vendor coordination), maintenance of configuration specifications, and drafting/updating site IT SOPs.
The contractor partners with Quality/CSV to help maintain the validated state of systems by implementing and documenting controlled technical changes in accordance with site procedures and regulatory expectations.

Roles & Responsibilities:

Serve as the IT technical point of contact (SME) for assigned GxP computerized systems (e.g., laboratory and manufacturing support systems), ensuring availability, reliability, and compliance-aligned configuration.
Perform system administration tasks including user/account provisioning, periodic access reviews, role and privilege configuration, audit trail enablement and verification, time synchronization checks, and controlled parameter settings per approved specifications.
Coordinate troubleshooting and resolution of system issues by engaging internal IT teams and system vendors for triage, root-cause investigation, patches, hotfixes, and service requests; document incidents and outcomes per site procedures.
Draft, update, and maintain Configuration Specifications (CS), system build and restore instructions, and other technical documentation defining approved system settings and architecture.
Draft, update, and maintain site IT SOPs and work instructions related to GxP system administration, including account management, backup and restore, audit trails, cybersecurity controls, patching, and disaster recovery.
Manage and execute backups, restores, and disaster recovery activities, including periodic verification and testing, ensuring schedules and retention meet approved requirements.
Support controlled technical changes through the site Quality Management System (QMS) by executing IT tasks under approved change controls, providing impact and risk input, and ensuring evidence capture.
Implement and maintain baseline security controls for servers and workstations hosting GxP systems, including endpoint protection, hardening settings, and account policies, in alignment with cybersecurity standards.
Plan and perform system and infrastructure upgrades (hardware and software) in coordination with vendors, operations, and QA/CSV, ensuring technical readiness, rollback planning, and documentation updates.

Education & Experience:

Bachelor's degree in Information Technology, Computer Science, Engineering, or a related field, or equivalent relevant experience.
Minimum of 5 years of experience supporting GxP-regulated IT systems, including system administration and technical remediation, in a pharmaceutical, biotech, or similarly regulated environment.
Hands-on experience with vendor coordination, incident troubleshooting, and controlled change execution in a regulated setting.
Working knowledge of GxP principles, data integrity expectations, and applicable regulations and standards such as FDA 21 CFR Part 11; familiarity with GAMP 5 is a plus.
Strong documentation skills, including authoring and updating configuration specifications and IT SOPs.
bility to manage multiple priorities, communicate effectively with technical and non-technical stakeholders, and work efficiently in an on-site environment.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 4888648beeb3a3e388f01c5797cec6d2
Posted 30+ days ago

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