NL - CSV Engineer

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).