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.
Requirement
- 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.
Other information
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