LIMS Subject Matter Expert

SIRE LIFE SCIENCES; Leiden; On-site; EUR 65,000 - 85,000; Full time

Job summary

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

The candidate will harmonize paper methods, create digital templates, support validation and change controls, and train lab users on LIMS and digital

Qualifications

• Bachelor's degree or equivalent in Chemical Sciences, Life Sciences, or related field.
• 5+ years of experience in QC, QA, analytical testing, or IT within regulated environment.
• Hands-on experience with LIMS; LabVantage experience highly desirable.
• Experience as a LIMS Key User, Business Administrator, SME, or similar role preferred.
• Knowledge of GMP/GxP, laboratory testing, validation, and change-control processes.

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.

Skills

LIMS expertise

LabVantage experience

GMP/GxP knowledge

Quality control/assurance experience

Stakeholder management

Strong communication

Education

Bachelor's degree in Chemical/Life Sciences

Tools

LabVantage

LIMS

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.