Role: Manufacturing Technician
Location: Ringaskiddy Cork, Ireland
Reports to: Operations Team Lead
Janssen Sciences Ireland UC established its operation in Ringaskiddy in 2005 on a 100 acre site with an investment of €500 million. For more than 25 years we have been a global leader in the field of biomedicines, in particular pioneering monoclonal antibody technology a cutting-edge approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments.
In 2017, Janssen Sciences Ireland UC announced that it is to invest more than €300 million in the expansion of its manufacturing plant that will create more than 200 new jobs.
A Manufacturing Technician supports manufacture of quality biomedicines in accordance with cGMP and EHS requirements. Reporting to the Operations Team Leader, this position is responsible for day-to-day activities within the Operations department.
As a Manufacturing Technician, your typical day may include:
• Working assigned shift patterns to meet business needs and Operations schedule.
• Use of DCS (e.g Delta V), MES and PLC control systems to execute processing steps.
• Assembly and Disassembly of processing equipment.
• Integrity testing of process filters.
• Sampling of product streams, clean utilities and performance of environmental monitoring (routine and batch specific) according to site procedures.
• CIP/SIP of processing equipment.
• Cleaning and sanitization of Operations facility.
• First line maintenance and calibration of equipment.
• Support of Commissioning and Qualification activities.
There are 3 specific areas during the manufacturing process and each area has individual responsibilities and requirements outlined below:
Cell Culture Activities
• Media Preparation, filtration and storage.
• Assembly and disassembly of the Bioreactor vessels.
• Assembly and disassembly of cell culture recovery equipment (ATF/Biomass systems).
• Employ strict aseptic technique to all cell culture activities.
• Monitor and control, media harvest hold area.
• Continuous monitoring of cell culture process.
• Chromatography processing of biopharmaceutical product using Unicorn control system.
• Filtration, Ultrafiltration and Virus filtration of purified product.
• Final filtration , filling and finishing of purified product.
Bioprocess Supply Activities
• Assembly and disassembly of Operations equipment for cleaning and sterilization.
• Operation of washers and autoclaves to clean and sterilize equipment.
• Operation of COP and SOP booths.
• Buffer and media preparation.
Qualification and Experience:
• Leaving Cert combined with appropriate GMP Experience (2 Years minimum/GMP specific Qualification).
• Leaving Certificate with Scientific or Technical 3rd level Qualification.
• Ability to adhere to batch records, SOPs and work instructions.
• Ability to understand rationale behind tasks being performed.
• Operations experience within a GMP regulated environment.
• Operations experience within a Life Sciences or Biopharmaceutical environment.
• Experience of Microsoft Word, Excel and Outlook.
• Experience with automated systems and PLC controls.
• Experience in an SOP, ISO, or similar regulated environment strongly desired.
Janssen R&D Ireland (7566)