LIMS Specialist
LIMS Specialist in Leiden voor een wereldwijd biofarmaceutisch bedrijf; implementatie en digitalisering van labmethoden in een gereguleerde QC-omgeving.
- Locatie
- Leiden
- Werkvorm
- op locatie
- Sluitingsdatum
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Eisen
- Good knowledge of GMP/GxP requirements, laboratory testing, validation, and change-control processes
- Structured and analytical approach with strong attention to detail
- Hands-on experience working with LIMS
- Minimum 5 years of experience in Quality Control, Quality Assurance, analytical testing, laboratory systems, or IT within a regulated environment
- Ability to work effectively with both laboratory and technical teams in a regulated environment
- Bachelor's degree or equivalent qualification in Chemical Sciences, Life Sciences, or a related field
- Strong communication and stakeholder-management skills
Wensen
- Experience as a LIMS Key User, Business Administrator, Subject Matter Expert, or in a similar role
- Experience with LabVantage
Volledige omschrijving
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. 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 include leading the harmonisation and digitalisation of paper-based laboratory methods within a regulated QC environment; creating, configuring, and maintaining method execution templates, master data, and digital laboratory methods in LIMS; supporting validation activities, change controls, and technical documentation related to digital laboratory processes; managing updates and improvements to existing digital methods in collaboration with laboratory SMEs and other sites; supporting the setup, testing, and validation of LIMS-to-instrument interfaces and related digital laboratory workflows; acting as a key point of contact for laboratory users regarding LIMS, digital methods, and laboratory workflows; providing training and guidance to laboratory teams on digital methods and LIMS functionality; and collaborating with laboratory, Quality, IT, and technical stakeholders to ensure effective implementation and maintenance of digital laboratory solutions.
Requirements include a Bachelor's degree or equivalent qualification in Chemical Sciences, Life Sciences, or a related field; a minimum of 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; and a structured and analytical approach with strong attention to detail.
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