Experience: 6 - 15 Years

Must Have

Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.

Minimum of 6+ years of relevant experience in LIMS, ELN, and laboratory data analysis systems within a regulated environment.

Position Summary

We are seeking an experienced LIMS Master Data Manager to oversee the creation, deployment, and maintenance of master data management systems for our Laboratory Information Management System (LIMS). The ideal candidate will possess expertise in data integration across electronic systems such as LIMS, ERP, and MES, ensuring seamless system operations and continuous improvements.

Key Responsibilities • Develop and manage master data for LIMS applications, ensuring data accuracy and system integrity. • Perform system integration, data verification, and troubleshooting across multiple electronic systems. • Collaborate with Quality Control (QC) end users to identify system enhancements aligned with user requirements and business objectives. • Guide QC end users through User Acceptance Testing (UAT), User Requirement Specifications (URS) and other validation activities. • Drive improvements to electronic systems, enhancing business processes and operational efficiency. • Support QC management in developing strategic initiatives for mid- to long-term business needs. • Independently troubleshoot issues and propose effective solutions. • Translate business requirements into technical specifications and work with partner organizations, such as IT, to implement solutions. • Conduct additional tasks as necessary to support electronic system operations.

Minimum of 6+ years of relevant experience in LIMS, ELN, and laboratory data analysis systems within a regulated environment.

In-depth understanding of Global Regulatory and cGMP requirements and the ability to apply them effectively.

Strong problem-solving skills with a logical and analytical approach to complex challenges.

Exceptional communication skills to convey complex technical concepts to peers, department management, and cross-functional teams.

Skillful in mentoring, coaching, influencing, negotiating, and personnel interactions.

Ability to thrive in a fast-paced team environment, manage multiple priorities, and meet deadlines consistently.

Bachelor's degree in Science, Engineering, or a related field is required.

Prior experience with validation and maintenance of laboratory information systems is essential.

Demonstrated proficiency in technical writing for system documentation and validation reports.