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

IM Lab Automation Analyst

Job Description