About the job
We are seeking a motivated and detail-oriented Laboratory Automation Analyst to oversee and facilitate IT operations associated with a strategic initiative for Laboratory Automation System deployments within our Quality Control (QC) and Research & Development (R&D) laboratories. This position is critical in managing project execution, system validation, change control, vendor collaboration, user assistance, and regulatory compliance in a Good Manufacturing Practice (GMP) environment.
The successful candidate will collaborate with a cross-functional project team, playing a pivotal role in the effective delivery, validation, and transition of laboratory automation systems into operational use.
Key Responsibilities
Project Management & Implementation
Lead the project management efforts for the deployment of Laboratory Automation Systems across QC and R&D labs.
Engage in project planning meetings, daily updates, and technical support discussions.
Coordinate closely with laboratory system vendors and their technical teams during the commissioning and rollout phases.
Change Control & Compliance
Ensure all modifications and updates to laboratory applications adhere to Change Control procedures.
Follow GAMP guidelines, cGMP, 21 CFR Part 11, internal policies, and external audit standards.
Guarantee compliance with Computer System Validation (CSV), Data Integrity, and IT Security protocols.
Validation & Documentation
Create, execute, and maintain validation documentation for laboratory automation system implementations.
Develop and uphold Standard Operating Procedures (SOPs) and Work Instructions to facilitate system handover from project to production.
Assist in troubleshooting issues encountered during system commissioning, ensuring efficient problem resolution.
Document, analyze, and trend system issues to ensure successful implementations and prevent recurrence.
Provide support for incidents logged via the Helpdesk, ensuring Service Level Agreements (SLAs) and support metrics are achieved.
Effectively manage laboratory automation support calls.
Training & Knowledge Transfer
Deliver user training on new laboratory automation applications prior to system handover.
Facilitate knowledge transfer to operational and support teams.
Skills & Competencies
Proficient project management and organizational skills.
Exceptional interpersonal and communication abilities.
Strong analytical and problem-solving capabilities.
Ability to work independently and collaboratively within a multi-disciplinary team.
