Katalyst CRO · 16 hours ago
CSV Technical Engineer
Coral Springs, FL
Contract
Onsite
Senior Level
5+ years expKatalyst Healthcares & Life Sciences is seeking a CSV Technical Engineer to provide hands-on IT support for computerized systems used in GxP operations. The role involves system administration, technical troubleshooting, and maintaining the validated state of systems in compliance with regulatory expectations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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