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Validation Engineer - Laboratory Engineer - Automation

Eingestellt von Elevate Direct

Gesuchte Skills: Engineer, Engineering, Support

Projektbeschreibung

VALIDATION/LABORATORY ENGINEER/LEIDEN, NETHERLANDS/6 MONTHS CONTRACT/38 TO 61 EUR (PER HOUR)

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 Team Leader 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)
- Team player

THE COMPANY

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, click and action that email and your application will be visible to the hiring organisation directly.

Projektdetails

  • Einsatzort:

    Leiden, Niederlande

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Elevate Direct