Job Description
LEO Pharma Cork are currently recruiting a Process Operator to join our team on a permanent basis - Apply Today!
LEO Pharma is uniquely positioned to make a significant difference for patients. We focus on high-risk patient groups and supporting healthcare systems with high quality medicines. With 80 years’ experience, we empower healthcare professionals with expert treatments for illnesses involving blood clots and other critical-care conditions.
In Production we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals. The ideal candidate will be able to work independently as well as part of a small team.
Your Role
The Process Operator works as part of the team coordinated by the Process Flow Specialist and reports to the Operations Manager. Key responsibilities include:
• Maintaining production of Heparin Intermediates and API’s according to established Standard Operating Procedures.
• Workng in compliance with cGMP in accordance with Irish, European Union and FDA regulations, including Health, Safety, Security and Environmental procedures
• Completing all stock transactions on the Stock Control System.
• Compliant handling of chemicals including Heparin, Ethanol, Celkate and Glacial Acetic Acid.
• Effective control of starting materials, intermediates and API’s, including weighing, measuring, labelling and reconciliation of production materials.
• Completion and maintenance of batch manufacturing records, log sheets, in-process control sheets.
• Fulfilling all sampling requirements specified on Batch Manufacturing Records.
• Operation of all Production Equipment including associated valves, pumps, services and utilities.
• Preparing fittings for Autoclaves: Filter Housing, Container Closure, Pipe Fitting, Sampling equipment.
• Cleaning and disinfection of production area.
• Participation in performance improvement initiatives.
Operator duties may also include:
• Receipt of raw materials to the warehouse.
• Receipt and labelling of raw materials in the warehouse.
• Receipt of pure ethanol to the tank farm.
• Back-loading of regenerated ethanol to a tanker.
• Start-up, shutdown and running of the ethanol distillation column.
• Control and calibration of effluent pH and relevant logbooks.
• Active participation in Lean Manufacturing Initiatives.
Please note: This role requires shift working and the site currently runs 24/5 so flexibility is required.
Your Qualifications
To succeed in this role, we imagine that you have the following qualifications:
- Level 5 Certificate in a technical field such as science, chemical or industrial engineering, or equivalent by experience.
- Experience of working in API manufacturing, biotechnology or bioprocessing.
- Experience of working in a GMP regulated environment.
LEO Pharma is built on collaboration, innovation and curiosity. Is this you? Can you bring this and LEAN and Six Sigma philosophy, strong attention to detail with a quality focus mindset to the role?
Your Application
You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.