Laboratory Engineer - Validation - LIMS
Posted Mar 13
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)
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