Feb 212018

A multinational pharmaceutical company providing innovative medicines in areas of health where there is urgent need for better treatments.

Yacht Life Sciences has a vacancy for a Process Engineer at the Pharmaceutical Technology department of our client.

As a Process Engineer you are responsible for:

  • Build, maintain and provide expertise/know how about Pharmaceutical Technology and Primary Packaging Processes in liaison with Pharmaceutical Development Department (EU) and Pharmaceutical Technology Labs (Japan)
  • Build and maintain a network of expertise about pharmaceutical technology by liaison and partnering with Industrial and Academic Organizations
  • Document know-how and expertise as reports, procedures, instructions, manuals for end-users
  • Propose, define, implement and document Changes and Modifications to manufacturing and packaging processes in order to improve robustness and compliance, reduce variability, increase yields and efficiencies
  • Contribute to design and review of regulatory dossiers describing and documenting the manufacturing and packaging processes
  • Participate and contribute to Product Maintenance process, collaborating with SC&M, PDD, QA and Regulatory departments
  • Contribute to risk-assessments as input for validation-projects,  investment projects or other relevant areas
  • Approve process recipes and master batch records
  • Monitor and analyse processes based on data from various equipment, batch-records, ERP-system, LIMS-system and correlate process performance to other phenomena
  • Contribute to investigations on request to analyse causes of variability, deviations, trends etc, in cooperation with Production and Quality Management 
  • Contribute to definition of User Requirement Specifications of Process Equipment and Systems, to ensure match between Product-Specifications, Process-Parameters and Equipment Configuration and Capabilities
  • Provide training sessions and training materials to people involved in execution of the processes, in collaboration with training and efficiency manager
  • Design and execute experiments on small (pilot-) scale to get understanding of process dynamics and opportunities for optimisation
  • Design, execute and report experiments to support the regulatory change control process
  • Manage Technology Transfer Projects:
    • Processes developed by other Entities or Third Parties to implement at location
    • To transfer processes to other manufacturing sites or entities
  • Perform maintenance tasks for Technology Unit (i.e. sampling of water, monitoring of calibration, monitoring of cleaning, monitoring of maintenance)

  • Bachelor/Master degree in Pharmaceutical Sciences, Chemical Technology, Food Technology or equivalent
  • >3 years relevant work experience within the pharmaceutical industry
  • Experience with processes such as granulation, tabletting, and/or coating
  • Experience working under GMP conditions
  • Fluency in Dutch and English

Full-time position. You will start with a 1 year contract.

Match criteria: Medical Practice, Researcher, Quality Assurance, Chemical engineering, Mechanical engineering, Facility Coordinator, 40 hours, Prov. Drenthe, Non

Company name: Stepstone NL

click here for more details and apply to position

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Questions to ask
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