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  • Location

    Haarlem, Netherlands

  • Job title:

    Commissioning & Qualification Engineer

  • Sector:

  • Job ref:

    45116

  • Start Date:

    2020-10-12

Company

The company has a Biotech and Pharmaceutical operations site. They are one of the biggest innovative companies in the Netherlands and they are specialized in vaccines, biological therapies and medicines.

Responsibilities

Primary responsibilities for the Commissioning and Qualifications Engineer include:

  • Commission and Qualify (C&Q) various process and laboratory equipment.
  • Design and execute process validation studies for the large Scale API processes.
  • Review and assess change control for API processes to determine impact on validated state.
  • Apply Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
  • Participate in efficiency and streamlining projects contribute to process improvement, technology transfer, new product introduction and other projects.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc. Position will receive direction and support.

Qualifications

  • Requires degree in Mechanical or Chemical Engineering.
  • Pharmaceutical/biotech experience, sterile manufacturing C&Q experience a plus.
Contact Us

SIRE LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE LIFE SCIENCES DEUTSCHLAND GmbH

Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SINCERE. INTELLIGENT. RESULT-DRIVEN. EXCELLENCE.