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2 weeks ago
We are seeking a highly skilled Lead Laboratory Systems Professional to join our Technical Operations Team. This role will be responsible for supporting the implementation and configuration of laboratory systems across the site and AR&D, driving proactive programs to enable the site to deliver the pipeline.
Main Responsibilities:- Data Management Systems SME: Act as the Subject Matter Expert on data management systems for instrument control in the laboratories, including LIMS, Waters Empower, LabX, Softmax Pro, and other laboratory instrument controlling software.
- Lab IT Systems Development: Build the lab information technology systems to support tech transfer/commercialization and manufacturing of biologics.
- System Performance Monitoring: Monitor and support the performance of the site laboratory systems according to cGMP and Systems Development Life Cycle (SDLC) standards.
- Industry Best Practices Implementation: Implement industry best practices specific to laboratory systems processes that support sample management, testing, and validation.
- Compliance and Regulatory Support: Ensure site laboratory systems comply with changing requirements and trends in worldwide GMPs.
- Degree qualification in a technical discipline (biochemistry / chemistry / engineering).
- At least 2 years' experience in laboratory systems.
- Previous experience with configuring, building, maintaining laboratory management systems such as LIMS, LabX, Empower systems, and an interest in coding/script.
- Experience working in a GMP regulated pharma/biopharma company or related industry is desirable.
This role requires a strong understanding of analytical methodology, GMP, ICH, USP, and global compendia regulations, particularly as related to analytical method development and validation.
About This Opportunity:This is an excellent opportunity for a skilled professional to make a significant impact in our organization. If you have the required skills and experience, we encourage you to apply for this challenging and rewarding role.
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