IT-CSV Engineer

Title: IT-CSV Engineer

Location: Durham, NC (Onsite)

Duration: 6 months, with potential for extension

Start Date: ASAP

Hours: 40 hours per week

Position Overview

We are seeking an experienced IT Data Integrity Systems Engineer to support data integrity initiatives for Quality Control (QC) laboratories and manufacturing equipment in a regulated pharmaceutical environment. This role will focus on implementing and maintaining IT infrastructure, backup and recovery solutions, software controls, and compliant computerized systems while ensuring adherence to GxP, Computer System Validation (CSV), and regulatory data integrity requirements.

Key Responsibilities

• Support the implementation and qualification of data integrity initiatives, including Acronis backup and recovery solutions.
• Perform software upgrades and implement additional software controls for QC laboratory instruments and manufacturing equipment.
• Implement and maintain secure USB access control processes.
• Install, configure, and maintain laboratory computer systems and workstations across QC laboratories and manufacturing areas in compliance with GxP and Quality requirements.
• Provide IT administration and technical support for QC instruments, manufacturing equipment, and associated computer systems at the Durham, NC site.
• Collaborate with QC and Manufacturing teams, instrument vendors, and third-party service providers to prioritize activities and resolve technical issues.
• Support laboratory computing projects, including new system installations, configurations, integrations, troubleshooting, and issue resolution.
• Maintain IT infrastructure and computerized systems, ensuring appropriate access controls, system security, backup processes, and data integrity.
• Manage user accounts and groups through Microsoft Active Directory.
• Author, update, and maintain IT Standard Operating Procedures (SOPs) and Work Instructions throughout the system lifecycle.
• Ensure computerized systems and IT processes comply with applicable regulatory requirements, including 21 CFR Part 11 and EU Annex 11.

Required Qualifications

• Bachelor’s degree in Information Technology, Computer Science, or a related field, or equivalent certifications and experience.
• Minimum of 3 years of IT experience within the pharmaceutical or biotechnology industry.
• Strong understanding of IT infrastructure, including networking, PCs, telephony, and virtualized environments.
• Hands-on experience managing and configuring Linux and Microsoft Windows Server operating systems.
• Working knowledge of Computer System Validation (CSV), data integrity principles, and GxP requirements for computerized systems.
• Familiarity with 21 CFR Part 11, EU Annex 11, and applicable data integrity controls.
• Experience managing users, groups, and access permissions in Microsoft Active Directory.
• Strong troubleshooting, analytical, documentation, and communication skills.
• Ability to work independently, manage competing priorities, and maintain compliance in a regulated environment.
• Strong attention to detail and a quality-focused approach to IT system administration and support.

Preferred Qualifications

Experience supporting laboratory instruments, manufacturing equipment, or associated software systems, including any of the following:

Manufacturing and Cell Processing Equipment:

• Rotea, Sepax, LOVO, Cue, Prodigy, and MaxCyte.
• Skid controllers and platform integrations with DeltaV.

QC Laboratory Instruments and Software:

• SpectraMax, Zetasizer, MACSQuant, SoloVPE, and Hamilton systems.
• BacT/ALERT systems with MYLA software.
• Similar laboratory instruments and computerized equipment used in pharmaceutical or biotechnology environments.

Experience with backup and recovery solutions, software qualification, secure access controls, and laboratory or manufacturing system integrations is highly desirable.