Johnson & Johnson
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.
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.
- 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).