Ecocareers · 13 hours ago
CSV Technical Engineer
Coral Springs, FL
Full-time
Onsite
Senior Level
5+ years expConfidential company is seeking a CSV Technical Engineer to provide hands-on IT support for computerized systems used in GxP operations at the Coral Springs site. The role focuses on system administration, technical troubleshooting, maintenance of configuration specifications, and drafting/updating site IT SOPs to ensure compliance and system validation.
Staffing & Recruiting
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
Qualification
Required
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
Ability to manage multiple priorities, communicate effectively with technical and non-technical stakeholders, and work efficiently in an on-site environment
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase