Laboratory Systems Business Specialist

Summary:
An amazing opportunity has arisen for a Laboratory Systems Business Specialist to work for our client, a biopharmaceutical company in Dunboyne. This role will support the 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:

• 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), DME (Digital Method Execution – Labware ELN), Lonza MODA and Waters Empower.
• Work within an environment of Right First Time, through a focus on principles of lean, including simplification, standard work, and visual management.
• Build the Lab IT Systems to support Tech Transfer/Commercialisation of the biologics pipeline.

Qualifications & Experience:

• Degree qualification in a Technical discipline.
• At least 2 years’ experience in laboratory systems.
  Previous experience with configuring, building, maintaining laboratory management systems such as LIMS/ MODA and /or Empower systems and interest in coding/ script.
• Working understanding of GMP, ICH, USP and global compendia regulations and guidance’s, particularly as related to analytical method development and validation.
• An understanding in analytical methodology (e.g. HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays, PCR, capillary electrophoresis, compendial assays).