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Operations

Operator USP/DSP

  • 标题 Operator USP/DSP
  • 功能 Operations
  • 子功能 Production
  • 工作地 Leiden, South Holland, Netherlands
  • 发布时间
  • 申请ID 2206059354W
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描述

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.

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The Pollux production facility is currently under initial design development, with many milestones in the long lead plan.

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 Manufacturing Operator (USP/DSP) 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.

Job Summary:

Department Up Stream Processing (USP)

The core task of the USP department is the culturing of cells and infecting those with a virus. The team is most likely working in an 8/7 shift roster.

  • Storage and control of cell banks

  • Thawing of cells

  • Culturing and inoculation of cells in Shaker Flask and Wave bag (e.g. cell count, dilution, sampling)

  • Installing and preparation of SUBs

  • Inoculation of SUB,

  • Daily monitoring of SUBs including in process testing (e.g. cell count, pH)

  • Preparing transfection mix (process additions) and transfection

  • Harvesting SUB

  • Sample handling for both UPS department

Downstream Processing department (DSP)

DSP is responsible for the purification and filling using various techniques. During the project phase you will work normal weekdays. However, in full operation DSP consists of 3 sub teams, with each 8-10 operators, working in shifts. The shift roster is most likely 16/7.

The core task of the DSP is the purification and filling using various techniques, including:

  • Clarification of harvest

  • chromatography

  • Ultrafiltration and filtration

  • Preparation of Benzonase solutions (process additions)

  • Sample handling for both DSP department

Filling

  • Preparation of Isolator and filler

  • Filling of product in a grade A isolator

  • Aseptic working in an isolator working with highly automated filling robot

  • Reconciliation of batch

Visual examination

  • Visual examination of product vials

  • Labelling vials

  • Reconciliation of batch

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.

  • Perform process and documentation activities” escalate process deviations, notice process gaps and solve them, train operators.

  • Continuous improvement of work process and procedures.

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”!

Requirements

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

资格

 

  • Preferred is a (MBO) degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).

  • 1-3 years’ experience in a biotechnology or biopharmaceutical industry environment (manufacturing operator).

  • Demonstrated experience of 1 year in a BSL2 environment, with expertise in cell culture and virus propagation (USP) or purification (DSP), GMP and EHS standards.

  • Good communication in English, both verbally and in writing.

  • Knowledge of ISL, 5S and Kanban systems.

Key Competencies:

  • 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.

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