Senior Manufacturing Operators Fill & Finish
Project Pollux is the establishment of a new Janssen Supply Chain Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands to be organized as a new business unit for Janssen Biologics (JBV). This biologics manufacturing facility is intended to become a key supply option for commercial LVV in support of the global Janssen BCMA CAR-T program for multiple myeloma, a disease affecting ~160,000 patients annually.
The Pollux production facility is currently under construction, with the following milestones in the long-lead project plan:
· Completion of preliminary engineering (Basis of Design)
· Completion of full (detailed) design
· Facility construction and building commissioning
· Facility and production equipment qualification
· Producing validation batches, site approval, start routine production
Are you energized to support a new organization within a global company? Do you want to contribute to improve the life of patients? Do you have a strong passion for people? Then this is your job!
For this project Janssen Biologics is recruiting a Senior Manufacturing Operator (USP/DSP/F&F) to work within the Operational Readiness department to support this new facility now and in the future.
Shift Operations organization
In full operation, Shift Operations manufactures the Lenti Viral Vector for our customers. This process is following different steps from cell expansion, virus production and clarification to automated filling and labelling. The process is performed under strict GMP and BSL2 conditions. During the project the team is preparing the plant for operations and supporting the technology transfer from R&D by developing procedures and training, and the team will produce test and qualification batches.
Fill and Finish department (F&F)
F&F is responsible for the final filling and preparing the product for freezing and storage. During the project phase you will work normal weekdays. However, during start-up operation F&F consists of 3 sub teams, with each 4 operators. The shift roster will be primarily dayshift, with 2 late shifts once every three weeks.
The core task of Fill & Finish is the final Filling using various techniques, including:
• Preparation of Isolator and filler
• Filling of product in a grade A isolator
• Aseptic working in an isolator working with automated filling robot.
• Visual examination of product vials
• Labelling of vials, and Storage of the product in the DS freezers
The responsibilities and the impact YOU will have:
Support the installation and operation of new equipment, writing job breakdown sheets for training and work instructions.
· Cooperating in the execution of the daily task and the supporting activities of the department according to a detailed schedule.
· Monitoring progress and checking whether the activities are being carried out correctly.
· Continuous improvement of work process and procedures.
We would love to hear from YOU, if you have the following essential requirements:
Capabilities identified as priority for our Workforce of the Future are:
· Digital & Technology
· Change Leadership
· Critical Thinking & Problem Solving
· Process knowledge & expertise
· End to End mindset
· Preferred is a degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education), at minimum relevant education on MBO level 4 or higher.
· Demonstrated experience of 2 - 6 years in a BSL2 environment, with expertise in Fill & Finish (F&F), GMP and EHS standards.
· Good communication in English, both verbally and in writing.
· A certified Lean Yellow or Green Belt is preferred.
· Knowledge of used management systems (I.e., Trackwise QEM, SAP, eLIMS)
· Analytical ability and dealing with complexity.
· High degree of accuracy, initiative, and independence.
· Flexible, can deal with changing priorities, and stress resistant.
· “Can do” attitude, critical and proactive.
· Trainer skills, preferably train the trainer certified and TWI experienced.
· Good communication in English, both verbally and in writing (preferably also in Dutch).
· Able to work in shifts.
This is what awaits YOU at J&J:
· An opportunity to be part of a global market leader.
· A dynamic and inspiring working environment.
· Career opportunities and continuous personal and professional development in areas of technology and leadership.
· Personal Development Plan – such as access to further education & training, mentoring and coaching, development opportunities on-the-job or through exciting projects.
· Be part of a strong global network of talent and expertise, with opportunities to learn or move to different cultures and work environments.
· Many employee benefits.
· We are an equal opportunities employer.
Our Commitment to Diversity, Equity, & Inclusion:
· For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
· We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
· Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!