An amazing opportunity has arisen for a Laboratory Systems Specialist. This role will support the Testing SDWT/Hub for testing of incoming raw materials, in-process drug substance/drug product, stability samples and environmental monitoring of the controlled manufacturing areas and utilities areas.
Responsibilities
The motivation to be an inspiring member of a high performing team.
The desire to continuously learn, improve and develop.
Be the SME on data management systems for instrument control in the laboratories, this includes but is not limited to GLIMS (Global Labware LIMS Platform), Laboratory Execution Systems (LES), Lonza MODA and Waters Empower.
Work within an environment of right first time in everything that we do, through a focus on principles of lean, including simplification, standard work, visual management
Build the Lab IT Systems to support Tech Transfer/Commercialisation of the biologics pipeline
An understanding in analytical methodology (e.g. HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays, PCR, capillary electrophoresis, compendial assays).
A working understanding of GMP, ICH, USP and global compendia regulations and guidance’s, particularly as related to analytical method development and validation.
The candidate will have strong problem solving and trouble shooting skills
Qualifications
Degree qualification in a Technical discipline.
At least 2 years’ experience in laboratory systems, Labware LIMS experience preferred.
Previous experience with configuring, building, maintaining laboratory management systems such as LIMS/ MODA and /or Empower systems and interest in coding/ script.
Ability to think logically and be proactive under pressure.
Ability to work as part of a team and on own initiative in a constructive manner.
Flexible and self-motivated.
Purpose Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control...