Manufacturing Operations Specialist

Location Netherlands
Discipline: Pharmaceutical
Contact name: Talitha van Romondt

Contact email:
Job ref: 19236
Published: about 1 month ago

Manufacturing Operations Specialist



For one of the largest pharmaceutical companies, we are looking for a Manufacturing operations specialist. You will be responsible for representing operations on NPI tech transfer teams, manufacturing readiness for the NPI and supporting first line trouble-shooting of the day to day activities within Operations.



  • Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
  • Monitoring and reporting of process performance using statistical process control Investigating and resolving issues raised within the Manufacturing Department Participate in/ Lead Cross Functional teams when required
  • Preparation and updating of Batch Records, Procedures and Work Instructions
  • Provide process and equipment related training as required within the Manufacturing Department
  • Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
  • Managing the QI.
  • Compliance with Manufacturing and general site procedures at all times.
    Completion of all documentation in compliance with site procedures and GDP.
  • Lead and Support investigation and resolution of problems on plant.
  • Generate and assist with generation, review and revision of Manufacturing documentation as necessary.
  • Support ongoing studies by Validation, OTS and other support functions.


Your Profile

  • A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering

  • Manufacturing experience within a GMP regulated environment

  • Experience of the cell culture or purification processes

  • Project / New equipment installation experience

  • Process engineering experience

  • Commissioning and qualification experience

  • Postgraduate Qualification.

  • Generally, Requires 2-4 Years Work Experience



  • Location: Leiden, NLD
  • End date: 31/07/2023 (potential for Permanent position)
  • Full time, On site
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