Manufacturing Operator

We are searching for the best talent for a Manufacturing Operator to be in Sassenheim, Netherlands!

Join our team at the new fully digital Lenti Viral Vector Facility in Sassenheim, aimed at producing Lenti Viral Vectors for multiple myeloma treatment, impacting 160,000 patients worldwide. As we prepare for commercial production starting mid-2025, Janssen Biologics is seeking a Manufacturing Operator (USP/DSP/F &F) for our Operational Readiness team. You'll be essential in supporting facility operations, which include cell expansion, virus production, purification, and automated filling under GMP and BSL2 conditions. If you're passionate about innovation and teamwork, we want you to be part of this groundbreaking opportunity! Check out where we are located

About the departments:

Department: Upstream Processing (USP)
The USP department focuses on the culturing of cells and infecting them with a virus. The team operates on an 8/7 shift roster. Core tasks include:

• Culturing and inoculation of cells in Shaker Flask and Wave bag (e.g., cell count, dilution, sampling)
• Daily monitoring of cell culture including in-process testing (e.g., cell count, pH)
• Preparing transfection mix (process additions) and executing transfection
• Preparing Benzonase solutions (process additions)
• Harvesting SUB and clarifying the harvest
• Sample handling for the USP department

Department: Downstream Processing (DSP)
The DSP department is responsible for the purification of Lenti Viral Vectors using various techniques. During the project phase, you will work normal weekdays. The DSP team will consist of 10 operators on a day shift roster. Core tasks include:

• Purification using Ion Exchange chromatography
• Sterile filtration, including PUPSIT filter integrity testing
• Ultrafiltration and diafiltration
• Sample handling for the DSP department

Department: Fill and Finish (F&F)
The F&F department is responsible for the final filling and preparation of the product for freezing and storage. During the project phase, normal weekdays will be worked. Initially, the F&F team will consist of 3 sub-teams, each with 4 operators, primarily on a day shift roster, with 2 late shifts every three weeks. Core tasks include:

• Preparation of isolator and filler
• Filling of product in a Grade A isolator
• Aseptic working in an isolator with an automated filling robot
• Visual examination of product vials
• Labelling of vials and storage of the product in downstream freezers

As a Manufacturing Operator, you will:

• Support the installation and operation of new equipment, writing job breakdown sheets for training and work instructions.
• Collaborating in the execution of the daily task and the supporting activities of the department according to a detailed schedule.
• Perform process and documentation activities” raise process deviations, notice process gaps, and tackle them, train operators.
• Continuous improvement of work process and procedures.

Qualifications/Requirements:

• Preferably an MBO or HBO in biotechnology, biochemistry, biomedicine, process technology (or equivalent education) with proven experience in biotech or biopharma manufacturing.
• Hands-on expertise in a BSL2 environment, focusing on cell culture, virus propagation, purification, or Fill & Finish, adhering to GMP and EHS standards.
• Strong English communication skills, with the ability to analyze complex situations and maintain high accuracy and independence.
• Adaptable teammate with a proactive approach, ready to tackle challenges and work flexible shifts.

Preferred Skills:

Administrative Support, Agile Manufacturing, Analytics Dashboards, Chemistry, Manufacturing, and Control (CMC), Communication, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Operational Excellence, Plant Operations, Process Optimization, Process Oriented, Project Administration, Regulatory Compliance, Self-Awareness

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