Lab IT Administrator

About the Position

Your vision. Our solutions.

We are seeking a Lab IT Administrator to provide end-to-end support for laboratory equipment and systems in a GxP regulated environment.

Responsibilities

As a Lab IT Administrator, you will be responsible for:

• Providing hands-on end user support, administration, and issue resolution for GxP controlled laboratory equipment, servers, desktops, and software packages.
• Troubleshooting and resolving complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.
• Executing routine system administration and maintenance activities.
• Ensuring proper user management processes are adhered to for all computerized systems.
• Administering lab system access requests.
• Authoring validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
• Assisting systems users with defining, authoring, and documenting system use in user, admin, and maintenance SOPs.
• Ensuring systems are in compliance with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, as well as requirements from EU Annex 11 and all Data Integrity standards and guidelines.
• Working closely with CSV Lead, System Integrator, and Site IT Team.
• Providing support during internal and agency inspections.
• Providing subject matter expert (SME) support for general troubleshooting, problem-solving, technical direction, and guidance to support overall business needs.
• Taking ownership of related tasks, working under minimal supervision, utilizing industry experience and best judgment to make tactical decisions, staying proactive, etc.
• Monitoring the system daily and responding immediately to security or usability concerns.
• Creating and verifying backups of data.
• Responding to and resolving help desk requests.

Requirements

• Bachelor’s Degree or Higher in a technical discipline.
• 5+ years of professional experience in the digital space.
• Excellent communication skills (written and oral).
• Ability to multi-task and handle tasks with competing priorities effectively.
• Experience identifying operational issues and recommending and implementing strategies to resolve problems.

Desired Qualifications

• At least 3 years of experience working in a similar position within a GxP regulated environment.
• Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end-to-end of life cycle documents (including systems use and administration procedures).
• Understanding of Data Integrity concepts is required.
• Excellent communication and written skills required.

We Offer

• Competitive salary
• Hybrid work model

About the Company

Your vision. Our solutions.

We are committed to providing innovative IT solutions and support to our clients. Join our team and contribute to our mission of delivering excellence in IT administration.

Thank you! We will be in touch shortly.