Key Skills

Job Description

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!

Core Responsibilities

Lead the digitalization and harmonization of paper-based laboratory methods within a regulated QC environment. Manage LIMS method templates, master data, and the validation of instrument interfaces.

Requirements

Requires a Bachelor's degree in Chemical or Life Sciences and over 5 years of experience in QC, QA, or laboratory IT. Proficiency with LIMS, specifically LabVantage, and knowledge of GMP/GxP standards are highly desired.