Pfizer LIMS Analyst in Brussels, Belgium
Our Pfizer Clinical Research Unit (PCRU) in Brussels is a state-of-the-art research facility with sixty inpatient beds dedicated to early clinical trials (Phase 1 & 2a studies). In addition to the clinical facilities to execute clinical studies, the PCRU houses a laboratory to support, on a daily basis, clinical & pre-analytical laboratory activities which are also encompassing safety & biomarker laboratory oversight.
For the lab, we are currently looking for a
The LIMS Analyst is responsible for the implementation of the LIMS system and ensuring that the system is maintained in a state which meets regulatory, technical, quality and safety expectations.
Provide technical support to the PCRU Lab staff. Responds to software and hardware failures as needed. Works with BT partners to resolve issues.
Respond to requests and queries around lab data in support of studies activities. Acts as data manager and is responsible for overall quality of lab data.
Actively participates in the implementation of the LIMS system for PCRU by supporting requirements definition, functional design, master data configuration, data migration, system validation, SOP development/revision, and end-user training.
Ensures the system is operating accurately after updates and changes.
Explores, validates, and supports new and existing LIMS peripheral hardware and middleware.
Discusses and challenges business requirements on a global and local level with Business Process Owners, LIMS users.
Provides daily technical support to LIMS users for safety laboratory operations.
Oversees and directs operation of the LIMS and middleware systems.
Provide support for Installations and updates of instruments in LIMS and troubleshoots any issues that trace back to folder management.
Creates, reviews and maintains data management documents and custom reports in LIMS and/or middleware thereof. Manages and groups data files by instrument in LIMS.
Set up reference ranges and reflex tests using simple scripting.
Sets up and maintains the active instrument folders, LIMS scheduled tasks and the instrument interfaces.
Troubleshoots issues with the data in and between LIMS and other EDCMS
Executes periodic scripts or SQL extracts.
Supports the LIMS interfacing of all new analyzers with the input of Instrument Owners.
Support LIMS improvement projects. Participates in global implementation of new LIMS features and enhancements.
Develops relationships with vendors to identify and leverage training opportunities. Creates, maintains and recommends training materials and trainings for end users.
Supports audits and inspections to provide data and information upon request.
Minimum of a Diploma bachelor degree in Medical Biology or equivalent (life sciences).
Significant track record of experience and accomplishment in clinical and/or research laboratory setting.
At least 3 years in Clinical Research or experience in analytical techniques and knowledge of analytical validation procedures, and managing projects.
Knowledge of ICH, and more specifically GCP. Understanding of the drug development process is a plus.
Working knowledge of computers. Knowledge of laboratory data handling acquisition systems (i.e. electronic lab notebook software) and associated issues/risks is a plus.
Willing to learn and master new computer interphases.
Good written and verbal skills in English, French and/or Dutch are essential.
Ability to communicate in easily understandable language for complicated research principles. Must be able to coach and assist less skilled or inexperienced personnel in the performance of laboratory activities linked to LIMS and related middleware.
Ability to establish a network (including with equivalent in NH-PCRU) and search for opportunities for collaboration and act upon them.
Comfortable with implementing changes.
Knowledge, skills, and abilities
Strong attention to detail and able to manage time and prioritize tasks to meet timelines.
Strong problem solving abilities.
Function as an effective and professional team member in diverse workgroups.
Excellent communication, planning and organization skills required.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.