Pharmaceutical Process Engineer

  • Amsterdam
  • 3500.00 - 5000.00
  • 32-40 uren
  • HBO

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world.

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence.

They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

functie Vereisten

  • Bachelors Degree
  • Pharmaceutical Experience - 3+ years strongly preferred
  • CAPA / RCA experience
  • Experience working in Quality Systems
  • Technology transfer experience strongly preferred
  • Cell Therapy experience would be a plus
  • English professional (and Dutch prefered)

Wat krijg je?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Werkzaamheden

  • Work closely with Process Development teams to assure process reliability and robustness in preparation for comparability and process validation.
  • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
  • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
  • Work with vendors and suppliers to define requirements and understand functional specifications
  • Support investigation identify root cause for critical deviations to maintain routine manufacturing operations and determine CAPA for manufacturing.
  • Write and review technical documentation (batch records, SOPs, protocols & reports for equipment qualifications, comparability, process and cell therapy manufacturing process validation testing).
  • Participate and report to a cross-functional development team to advance production activities.
  • Ensure successful manufacturing process comparability and process validation runs
  • Participate in laboratory experiments that support process development for extended process characterization, investigation resolution, and process improvements.

TAGCLOUD

Sander Pupella

Geïnteresseerd?

Stuur uw cv naar sander@tailorminds.com onder vermelding van vacature id (1059)

Meer informatie?

Neem contact op met Sander Pupella van ons kantoor te Zoetermeer, te bereiken op nummer +31 6-13140754

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