Johnson & Johnson

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Senior manufacturing operator PPIP

Job Description

Would you like to be directly involved in the fight against the global "Coronavirus" (COVID-19) pandemic? Then keep reading!


Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson and is passionate about the development, production and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where we proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV and Ebola. This is also the place where we will be producing the COVID-19 vaccine material.


To strengthen the department we are looking for an Associate Scientist / Senior manufacturing operator (PPIP - production person in plant), to help us realize the upcoming COVID-19 vaccine manufacturing campaign.

Department

The department DSO is an international team of about 40 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA and warehouse. Our passion is to deliver high-quality results to our customers and to seek opportunities for improvement: never a dull moment!

Within the department four teams operate, each with specific responsibilities: Preparations, Cell culture/ Upstream processing, Downstream processing and the Operations Support Team. The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues and performing the resulting corrective actions, masterbatch documentation, training and inspection readiness.

Job description

In this role you are primary responsible for acute problem solving of issues that manifest during operations to ensure the continuation of the production processes for cGMP clinical trial material. Analysing the issues and following up on the solution is your main task. For this, you will need to connect with specialists and partners inside and outside the department.

Apart from production operations you will be updating documentation to resolve the issues that you found. To improve the operations, small improvements and innovative projects will be a stable part of your daily work package. You will also be tasked in other small and divers tasks as well as reviewing batch documentation. As the job entails team work within a diverse and global organization, we require good communication skills in English.

Qualifications

The candidate...

  • has quality always as the main goal, efficiency second
  • is clear in communication, also under pressure
  • aims for full customer satisfaction. What is asked you to deliver with the required quality within the agreed timeframe?
  • has a high degree of accuracy, initiative, and independence
  • is flexible and stress-resistant and remains positive when priorities change
  • helps team members by giving advice and sharing feedback on technical and personal level
  • has great social and trainer skills, is able to provide and receive feedback in a constructive way. You make yourself part of discussions and help transform these into positive actions.
Qualifications:
  • HBO/BSc with 3 years of proven experience in pharmaceutical/biotechnology
  • Expert in cell culture (USP), virus propagation and/or downstream processing (DSP)
  • Experience with change controls, non-conformances and CAPA records
  • Experience with cGMP and EHSS standards is required
  • Lean green belt certification is preferred

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Vaccines & Prevention BV (8852)
Job Function
R&D
Requisition ID
2005823752W