LIMS Specialist

SIRE LIFE SCIENCES; Leiden; On-site; EUR 65,000 - 90,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a LIMS Specialist to drive the implementation, maintenance, and digitalisation of laboratory methods within a regulated Quality Control environment. You will focus on template creation, master data, validation, and harmonising paper methods into digital workflows.

You will support lab teams with digital processes, instrument interfaces, and LIMS-related activities, while collaborating with Quality, IT, and site colleagues to ensure compliant, efficient digital

Qualifications

• Bachelor's degree in Chemical Sciences, Life Sciences, or related field.
• Minimum 5 years in Quality Control, Quality Assurance, analytical testing, or IT within a regulated environment.
• Hands-on experience with LIMS; LabVantage experience highly desirable.
• Experience as LIMS Key User or SME preferred.
• Good knowledge of GMP/GxP, validation, and change-control processes.

Responsibilities

• Lead the harmonisation and digitalisation of paper-based laboratory methods within a regulated QC environment.
• Create, configure, and maintain method execution templates, master data, and digital laboratory methods in LIMS.
• Support validation activities, change controls, and technical documentation for digital laboratory processes.
• Manage updates and improvements to digital methods in collaboration with laboratory SMEs and other sites.
• Support setup, testing, and validation of LIMS-to-instrument interfaces and related digital laboratory workflows.
• Act as a key contact for laboratory users regarding LIMS and digital methods.
• Provide training and guidance to laboratory teams on digital methods and LIMS functionality.
• Collaborate with laboratory, Quality, IT, and technical stakeholders to ensure effective implementation and maintenance of digital laboratory solutions.

Skills

LIMS

GxP knowledge

Stakeholder management

Analytical thinking

Education

Bachelor's degree in sciences

Tools

LabVantage

Job description

The company

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

Role Description

As a LIMS Specialist, you will play a key role in the implementation, maintenance, and digitalisation of laboratory methods within a regulated Quality Control environment. You will focus on LIMS method templates, master data, validation, and the harmonisation of paper-based laboratory methods into digital workflows. You will also support laboratory teams with digital processes, instrument interfaces, and LIMS-related activities.

Responsibilities

• Lead the harmonisation and digitalisation of paper-based laboratory methods within a regulated QC environment.
• Create, configure, and maintain method execution templates, master data, and digital laboratory methods in LIMS.
• Support validation activities, change controls, and technical documentation related to digital laboratory processes.
• Manage updates and improvements to existing digital methods in collaboration with laboratory SMEs and other sites.
• Support the setup, testing, and validation of LIMS-to-instrument interfaces and related digital laboratory workflows.
• Act as a key point of contact for laboratory users regarding LIMS, digital methods, and laboratory workflows.
• Provide training and guidance to laboratory teams on digital methods and LIMS functionality.
• Collaborate with laboratory, Quality, IT, and technical stakeholders to ensure effective implementation and maintenance of digital laboratory solutions.

Requirements

• Bachelor's degree or equivalent qualification in Chemical Sciences, Life Sciences, or a related field.
• Minimum 5 years of experience in Quality Control, Quality Assurance, analytical testing, laboratory systems, or IT within a regulated environment.
• Hands-on experience working with LIMS; experience with LabVantage is highly desirable.
• Experience as a LIMS Key User, Business Administrator, Subject Matter Expert, or in a similar role is preferred.
• Good knowledge of GMP/GxP requirements, laboratory testing, validation, and change-control processes.
• Strong communication and stakeholder-management skills.
• Ability to work effectively with both laboratory and technical teams in a regulated environment.
• Structured and analytical approach with strong attention to detail.