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IT Lab Systems Specialist

Posted 2 days 3 hours ago by Merck Gruppe - MSD Sharp & Dohme

Permanent

Full Time

Laboratory Jobs

Leinster, Ireland

Job Description

An amazing opportunity has arisen for an IT Lab Systems Specialist to join our Digital Manufacturing Operations (DMO) Team at our state of the art, fully integrated vaccine facility in Dundalk Ireland.

You will play a key role in supporting GxP controlled laboratory systems through hands on administration, installation, troubleshooting, and upgrades, while helping ensure compliance, reliability, and smooth laboratory operations.

What you will do:

Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.
Perform laboratory equipment, hardware and software upgrades following corporate computer system validation policy and GMP best practices.
Represent DMO on digital strategies within the QC, MS&T and Manufacturing analytical equipment.
Work with Global IT teams on LIMS, Empower, and Moda upgrades/enhancements and issue resolutions.
Execute routine system administration and maintenance activities as required.
Create and/or execute software validation scripts to support laboratory.
Create and maintain system documentation including system design specifications, user requirements and functional requirements.
Proactively communicate with laboratory stakeholders and update helpdesk tracking software as necessary.
Ensure proper user management process is adhered to for all computerized systems.
Administer lab system access requests.
Participate in or lead computerized system software/solution provider audits.
Ensure systems are in compliance with our System Delivery Life Cycle (SDLC), to ensure in compliance with EU Annex 11, 21 CFR Part 11 and all Data Integrity standards and guidelines.
Work closely with Quality Assurance, Digital Data Quality, System Integrator and Site Business teams.
Prepare & complete all System Design Configuration Specification documentation.
Work with commissioning, qualification and validation (CQV) and site engineering to ensure successful start up of equipment.
Provide support during internal and agency inspections.
Provide subject matter expert (SME) support for general troubleshooting, problem solving, technical direction, change control and guidance to support overall business needs.
Provide project support for any projects in the DMO space, e.g. system upgrades, updates, new installations, remediations, migrations and system retirements.

What skills you will need:

Bachelor's degree in a technical discipline.
Minimum 2 years' experience in a similar position.
Experience working in a Pharma/Biopharma company or regulated industry.
Strong knowledge with GLIMS, Lab X, lab equipment data collection and storage.
Strong technical aptitude, global regulatory experience, and ability to interface with auditors or inspectors.
Ability to work as part of a team and independently, with strong organizational skills and proactive problem solving abilities.
Commitment to safety, continuous learning, and being an inspiring member of a high performing team.

Required Skills