Lab IT Administrator

HCL Technologies Limited; Dunboyne; On-site; EUR 55,000 - 85,000; Full time

Job summary

HCL Technologies Limited in Ireland seeks a Lab IT Administrator to deliver end-to-end support for lab users and stakeholders. You will manage lab IT systems, assist with validation and documentation, and ensure regulatory compliance across 21 CFR Part 11 and EU Annex 11.

The role requires strong communication and multi-tasking in a regulated environment. You will work with the Lab COE and local site DMO, coordinate with support teams, and contribute to inspections and readiness activities,

Qualifications

• Bachelor’s degree in a technical discipline is required.
• Minimum 5+ years of professional experience in the digital space.
• Excellent written and oral communication skills.
• Ability to multi-task with competing priorities and lead documentation efforts.

Responsibilities

• Provide hands-on end user support and admin for GxP lab equipment, servers, desktops and software.
• Troubleshoot complex lab IT issues across software, OS, hardware, network and interfaces.
• Execute routine system administration and maintenance tasks.
• Maintain user management for all computerized systems.
• Author validation, qualification and testing documents (IQ/OQ/PQ, etc.).
• Ensure 21 CFR Part 11 and EU Annex 11 compliance and data integrity standards.
• Collaborate with CSV Lead, System Integrator and Site IT Team.
• Assist with inspections and operational readiness activities.
• Provide SME guidance for troubleshooting and problem solving.
• Create backups and respond to help desk requests.

Skills

End user support

Documentation

Regulatory compliance

GxP familiarity

Problem solving

Education

Bachelor’s Degree in a technical discipline

Tools

21 CFR Part 11

Data Integrity

System validation

GxP lab systems

Job description

Lab IT Administrator role whose primary responsibility will be to work with Lab COE and local site DMO team to provide end to end support for the Business users & Stakeholders, Coordinate with Site for technical topics, Co-ordinate with Support team, etc.,

Role Functions (Functions include, but are not limited to, the following):

• As a Lab IT Administrator , you are responsible for providing 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 as required.
• Ensure proper user management process is adhered to for all computerized systems
• Author the typical 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
• Ensures 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. Ensure applicable standards and specifications are adhered to.
• Work closely with CSV Lead, System Integrator and Site IT Team.
• Work with operational readiness team and operations to ensure acceptable turnover.
• 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 the industry experience and best judgment to make tactical decisions, stay proactive, etc.
• Advanced knowledge of system vulnerabilities and security issues.
• 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

Qualifications & Education:

• 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