Lab IT Administrator

About the Position

We are seeking a Lab IT Administrator to provide end-to-end support for laboratory equipment and systems, ensuring compliance with regulatory standards.

Responsibilities

• Provide hands-on end user support, administration, and issue resolution for GxP controlled laboratory equipment, servers, desktops, and software packages.
• Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.
• Execute routine system administration and maintenance activities.
• Ensure proper user management process is adhered to for all computerized systems.
• Administer lab system access requests.
• Author 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.
• Assist systems users with defining, authoring, and documenting system use in user, admin, and maintenance SOPs.
• Ensure 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.
• Work closely with CSV Lead, System Integrator, and Site IT Team.
• Provide support during internal and agency inspections.
• Provide subject matter expert (SME) support for general troubleshooting, problem solving, technical direction, and guidance to support overall business needs.
• Take ownership of related tasks, work under minimal supervision, utilize industry experience and best judgment to make tactical decisions, stay proactive, etc.
• Monitor the system daily and respond immediately to security or usability concerns.
• Create and verify backups of data.
• Respond to and resolve 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 environment.
• Opportunity to work in a dynamic and innovative team.

About the Company

We are a leading company in the digital space, committed to providing high-quality services and solutions. Join our team and contribute to our mission of excellence.

Apply for this position

Our team will review your application within the next 5 days.

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