Manufacturing Technician (RTW – Reignite program)
Johnson & Johnson is currently seeking a Manufacturing Technician (RTW – Reignite Program) to join our manufacturing team located in Ringaskiddy, Cork on a 23-month FTC.
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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.
About Re- Ignite:
The Re-Ignite Program is designed to increase the pipeline of STEM2D (Science, Technology, Engineering, Math, Manufacturing and Design) talent who are returning from a two or more-year career break. This program provides the opportunity for professionals to get back into the workforce at a later life stage and offers a powerful return-to-work strategy for these individuals.
If you are ready to re-launch your career and are looking to grow and stretch with new opportunities, the Johnson & Johnson Re-Ignite Program is for you!
What you will be doing:
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. These activities include (but are not confined to):
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.
Purification Activities
- 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.
General Scope and Responsibilities:
- Execution of Operations activities as necessary to meet operational needs and strive to perform to the highest operational standards always.
- Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.
- Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements reporting any deviations promptly to the Team Lead.
- Carry out routine and non-routine tasks delegated by Team Leader according to appropriate procedures, values and standards.
- Completion of all documentation in compliance with site procedures and GDP.
- Ensure Operations areas are appropriately set-up to complete process steps and enforce good aseptic techniques always. Performing in process testing to support batch manufacture.
- Sampling of raw materials, product streams, clean utilities and performance of environmental monitoring (routine and batch specific) according to site procedures.
- Maintenance and calibration of Operations equipment, support in commissioning & qualification activities, and assist with generation, review and revision of Operations documentation.
- Support ongoing studies by Validation and other support functions.
- Segregation, processing and staging of Operations waste for off-site disposal and support investigation and resolution of problems and participate in Emergency Response/Fire/First Aid teams as necessary.
- Ensure that personal training requirements are completed when required with potential travel to other J&J sites and other external sites for training as required.