Lab Engineer

Location Netherlands
Discipline: Medical Device
Contact name: Talitha van Romondt

Contact email: t.romondt@panda-int.com
Job ref: 18954
Published: 15 days ago

For one of our largest Medical Device companies in Leiden, we are looking for a Lab Engineer.

In this role, you will ensure that quality systems are maintained and perform Quality Manager Inspection & Testing. You will be accountable for high quality products this is done by development and improvements of laboratory testing.

Responsibilities:

  • Evaluates compliance with applicable laboratory standards and procedures
  • Defining, developing and improving 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
  • Acts as a project leader for laboratory projects such as CIP
  • Implementation of corrective and preventive action and quality data trending for CAPA review board evaluation and perform audits observations/NCR/CAPA files from origination to full cycle completion and final approval
  • Test database maintenance (Labware LIMS program activities & SME)
  • Gathering & analyzing of test result data
  • Writing and bi-annual review of Service Level Agreements
  • Is responsible for annually review of Bioburden Data and Environmental Monitoring Data as part of routine trend analysis
  • Is responsible for quarterly trend report to be used in CRB
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Your profile:

  • Bachelor or Master 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;
  • Experienced with LIMS.
  • Experience with Validation.
  • Fluent in Dutch & English.

Practicalities:

  • Location: Leiden
  • Hybrid work model
  • Full time: 40 hours per week
  • Duration: Initially a 5 month contract, with possibility to extend
Interested?
 
Please get in touch today. For further information, please contact Talitha van Romondt at +31 (0)20 20 44 502 or by email at t.romondt@panda-int.com

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