LIMSSubjectMatterExpert

The Company
Our client is a global biopharmaceutical company committed to advancing innovative medicines that improve patients' lives worldwide. Through cutting-edge research, advanced biologics manufacturing, and a strong focus on quality and innovation, the company delivers life-changing therapies across a wide range of therapeutic areas.

Role Description
The LIMS Subject Matter Expert will lead the implementation and maintenance of digital laboratory methods within a regulated QC environment. The role focuses on LIMS method templates, master data, validation, paper-to-digital method harmonization, and supporting laboratory teams with digital workflows and instrument interfaces.

Responsibilities

• Lead the harmonization and digitalization of paper-based laboratory methods within a regulated QC environment.
• Create and maintain method execution templates, master data, and digital methods in LIMS.
• Support validation activities, change controls, and technical documentation for digital laboratory processes.
• Manage updates to existing digital methods and coordinate with laboratory SMEs and other sites.
• Support the setup and validation of LIMS-instrument interfaces and related digital workflows.
• Provide training and act as the main point of contact for laboratory users on digital methods and LIMS-related questions.

Requirements

• Bachelor’s degree or equivalent in Chemical Sciences, Life Sciences, or a related field.
• 5+ years of experience in Quality Control, Quality Assurance, analytical testing, laboratory systems, or IT within a regulated environment.
• Hands-on experience with LIMS; LabVantage experience is highly desirable.
• Experience as a LIMS Key User, Business Administrator, SME, or similar role is preferred.
• Knowledge of GMP/GxP, laboratory testing, validation, and change-control processes.
• Strong communication and stakeholder-management skills, with the ability to work effectively with laboratory and technical teams.

Other Information
Apply to our vacancy for more information. We look forward to hearing from you!

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