Job Summary

The IM Lab Automation Analyst will manage and support IT activities related to a planned program of Laboratory Automation System deploymentsacross Quality Control (QC)and Research & Development (R&D)laboratories.
The role involves project management, system validation, change control, vendor coordination, user support, and compliancewithin a regulated GMP environment.

Working as part of a cross-functional project team, the successful candidate will play a key role in ensuring the successful delivery, validation, and handover of laboratory automation systems into production.

Key Responsibilities

Project & Implementation

  • Project manage the implementation of Laboratory Automation Systemsacross QC and R&D laboratories.

  • Participate in project planning meetings, daily huddles, and technical support calls.

  • Work closely with laboratory system vendors and their technical support teams during system commissioning and deployment.

Change Control & Compliance

  • Ensure all updates and changes to laboratory systems and applications follow Change

  • Control procedures.

  • Adhere to GAMP guidelines, cGMP, 21 CFR Part 11, internal policies, and external audit requirements.

  • Ensure compliance with Computer System Validation (CSV), Data Integrity, and IT Securitystandards.

Validation & Documentation

  • Develop, execute, and maintain validation documentationfor laboratory automation system implementations.

  • Create and maintain SOPs and Work Instructionsto support system handover from project to production.

  • Support & Troubleshooting

    • Assist in problem determination and decision-making for issues encountered during system commissioning.

    • Record, analyze, and trend system issues to ensure successful implementation and prevent recurrence.

    • Provide support for incidents logged through the Helpdesk, ensuring SLAs and support metrics are met.

    • Monitor and manage laboratory automation support calls effectively.

    • Training & Knowledge Transfer

      • Provide user trainingon new laboratory automation applications prior to system handover.

      • Support knowledge transfer to operational and support teams.

      Skills & Competencies

      • Strong project management and organizational skills

      • Excellent interpersonal and communication skills

      • Strong problem-solving and analytical skills

      • Ability to work independently and as part of a multi-functional team

      • Experience working in regulated and fast-paced environments

      • Qualifications & Experience

        • Bachelor’s degree (BSc)in Information Technology, Computer Science, Engineering, or a related technical discipline

        • Minimum 3 years’ experiencein IT systems support and/or IT project implementation

        • Prior experience implementing Laboratory Automation Systems in a GMP environmentis desirable

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