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Johnson & Johnson

NL - CSV Engineer

Posted Sep 7, 2021
Job ID: JJJP00007601
Location
Leiden
Duration
1 year
(Oct 1, 2021 - Sep 30, 2022)
Hours/week
40 hrs/week
Payrate range
Unknown

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

 

Currently we are looking for a Computer System Validation Engineer for Mentor a Medical Device company of Johnson & Johnson.
 

JOB SUMMARY
The position of CSV Engineer reports directly to the Quality Manager Inspection & Testing. The CSV Engineer ensures that systems within the Quality system are adequately maintained and assist the Quality Manager Inspection & Testing as needed. Furthermore, the CSV Engineer is accountable for delivering a contribution to the making of high quality products this is done by development and improvements of laboratory testing.
 

DUTIES & RESPONSIBILITIES

  • 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.
  • 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 trouble shooting for test equipment and unexpected test results.
  • Gathering & analyzing 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.
  • Responsible for communicating business related issues or opportunities to next management level.
     

EXPERIENCE AND EDUCATION 

  • Bachelor or Master degree. Minimum of 2-5 years of related experience within Pharmaceutical and/or Medical Device companies, with relevant QC or QA experience.

 

REQUIRED KNOWLEDGE & SKILLS

  • Experience with Bluehill Universal and Windows 10.
  • Experience with IQ/OQ/PQ/CSV.
  • Familiarity with laboratory testing and automation.
  • High level of accuracy.
  • Trouble shooting 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 in Dutch or English.
  • Team player.
  • Basic knowledge of ISO 13485 is a plus.

 

EXTRA INFORMATION:

  • You can work 3 days on-site in Leiden and 2 days from home.
  • This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner YACHT. They can offer you a contract for the duration of the assignment at J&J, a one year contract or a freelance contract (ZZP).

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