Job Summary
The IM Lab Automation Analyst will manage and support IT activities related to a planned program of
Laboratory Automation System deployments
across
Quality Control (QC)
and
Research & Development (R&D)
laboratories.
The role involves
project management, system validation, change control, vendor coordination, user support, and compliance
within 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
The project manage the implementation of
Laboratory Automation Systems
across 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 Security
standards.
Validation & Documentation
Develop, execute, and maintain
validation documentation
for laboratory automation system implementations.
Create and maintain
SOPs and Work Instructions
to 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 training
on 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' experience
in IT systems support and/or IT project implementation
Prior experience implementing
Laboratory Automation Systems in a GMP environment
is desirable
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