Would you like to ensure that systems within the quality system are adequately maintained? Do you work with a high level of accuracy, and do you have a bachelor's or master's degree in Engineering, Science, or Microbiology? Keep reading!  

Functie

The position of Lab Engineer reports directly to the Quality Manager Inspection & Testing. Ensures that systems within the Quality system are adequately maintained and assist/replaces/back up the Quality Manager Inspection & Testing as needed and requested from a broader scope within the Quality Management system and as defined in the Duties & Responsibilities section of this document. Furthermore, the Lab Engineer is accountable for delivering a contribution to the making of high-quality products, this is done by developing and improvements of laboratory testing.

Under and in accordance with all applicable federal, state, and local laws/regulations and Corporate, procedures and guidelines, this position: Follows Standard Operating Procedures, Good Manufacturing Practices, Company policies, and Local Government Regulations:

  • Evaluates compliance with applicable laboratory standards and procedures.
  • SME during projects, regulatory, MDD, and notified body audits/inspections.
  • Defining, developing, and improving laboratory procedures.
  • Revise and maintain laboratory procedures.
  • Define and improve test method validations including protocols and reports.
  • Writing and developing IQ/OQ/PQ/ CSV protocols and reports for new and existing laboratory equipment.
  • Acts as a Test method, laboratory equipment validation, and other validation approvers.
  • Acts as a project leader for laboratory projects.
  • Participates, when necessary, in projects involving other departments and activities.
  • Coordination of non-routine laboratory testing activities including validation testing.
  • Implementation of corrective and preventive action and quality data trending for CAPA review board evaluation.
  • Work on Internal audit observations/NCR/CAPA files from origination to full-cycle completion and final approval.

Functie eisen

  • Bachelor or master’s degree in Engineering, Science, or Microbiology. 
  • Minimum of 2-4 years of related experience within Pharmaceutical and/or Medical Device companies, with relevant QC or QA experience. In-depth knowledge of ISO 13485.
  • Has an advanced broad and in-depth knowledge/familiarity with laboratory testing and automation.
  • Fluent in Dutch & English.
  • High level of accuracy.
  • Troubleshooting and analytical-minded.
  • Planning skills, ability to prioritize multiple commitments, and technical problem-solving ability.
  • Good interpersonal skills, engaged in contact with personnel at all levels within the organization.
  • Good communication skills, ability to write protocols/reports, business correspondence, and procedures.
  • Develops and presents new or improved test methods, solving laboratory problems in a timely manner. 

Aanbod

This is a responsible job with good employment conditions.

Sollicitatie Procedure

Contactpersoon voor deze functie als Lab Engineer is Olof Huiberts, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: olof@xdes.nl Kenmerk: 11008.

Solliciteer nu
  • Functienaam:
    Lab Engineer
  • Locatie:
    Leiden (Mentor Medical)
  • Branches:
  • Opleidingsniveau:
    |

Solliciteer

Vacature: Lab Engineer

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