MSAT Process Expert
Lonza
Porriño, ES
hace 1 día

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world.

While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.

In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Porriño is an integrated global contract manufacturing organization (CMO) offering a complete range of therapeutic protein manufacturing services.

We have the ability to provide these services in a fully scalable manner and at every stage of the development process. Our capabilities include technology transfer, analytical development and testing, scale up and cGMP manufacturing and support services.

As a member of the MSAT (Manufacturing Science & Technology) Team, you are the primary technical support person for manufacturing processes and perform technical administration activities to assist and support the process transfer or process manufacturing activities in the site in compliance with cGMP and customer requirements in respect of timing, accuracy and availability of information.

Key responsibilities :

  • Investigates deviations and assesses non-product quality impacting deviations.
  • Performs intermediate level data analysis such as non-standard calculations, means comparison, control charting.
  • Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently.
  • Assesses change controls for impact of any change to the process, equipment or procedures with assistance.

  • Represents MSAT on project teams and interfaces with customer technical and quality representatives. Represents MSAT on internal teams (e.
  • g. Deviation and Run Daily Management System meetings).

  • Participates in Customer Audits.
  • Key requirements :

  • Bachelor of Science, Field of Study Biological Sciences or Chemical Engineering
  • More than 5 years of experience in the production of biopharmaceuticals (Upstream / Downstream)
  • Experienced in aseptic technique and familiar with protein characterization assays.
  • Understanding of GMP regulations
  • Fluency in English and Spanish
  • Communication, technical writing, organizational and interpersonal skills.
  • Computer skills (including Word, Excel, Outlook and PowerPoint).
  • Analytical and problem solving skills.
  • Attention to detail and high level of accuracy.
  • People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.

    In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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