Laboratory Engineer - Validation - LIMS Posted Mar 13
Elevate Direct , Leiden, Zuid-Holland, Netherlands
  • This employer requests that only candidates in Netherlands apply to this job.

    You appear to be located in United States, not Netherlands, so you will not be able to apply for this job.

Laboratory Engineer - Leiden, Netherlands/6 months Contract/Up to 39 EUR (Per Hour)

Laboratory Engineer

Job responsibilities:

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 approver.

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 audits observations/NCR/CAPA files from origination to full cycle completion and final approval

Test database maintenance (Labware LIMS program activities & SME)

Support day-to day laboratory troubleshooting for test equipment and unexpected test results.

Gathering & analysing of test result data

Lead Costs Improvement (CIP) projects

Writing and bi-annual review of Service Level Agreements

Comply J&J Safety Requirements and ensure safe working conditions and practices in the department.

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

Delegated approval of labs and supplier quality related Non Conformances.

Verifying laboratory testing results

Replaces Quality Teamleader Inspection & Testing in absence.

Experience and qualifications:

Validation experience (must) or LIMS system experience/knowledge (to programming level)

- Master/Bachelor degree in Engineering or Science

Has an advanced broad and in-depth knowledge/familiarity with laboratory testing and automation

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

Pro Active, works independently, takes actions in the absence of specific instruction.

Develops and presents new or improved test methods, solving laboratory problems in a timely manner

Fluent English (Dutch plus)

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, and action that email and your application will be visible to the hiring organisation directly.

Employment Type: Contract
Duration: 6 months