Your new role
We are searching for a Lab Engineer who will ensure that systems within the Quality system are properly maintained. Alongside this, the Lab Engineer will also assist, replace and back up the Quality Manager inspection and testing as required. Essentially, the Lab Engineer will do validation of lab equipment as well as labware LIMS software system. The Lab Engineer’s responsibilities are as follows:
What you'll need to succeed
- 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;
- 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 trouble shooting for test equipment and unexpected test results;
- Lead Costs Improvement (CIP) projects;
- Writing and bi-annual review of Service Level Agreements;
- 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
BSc or MSc in Engineering or Life Science. Minimum 2-4 years of related experience within Pharmaceutical and/or Medical device companies, with relevant QC or QA experience. In depth knowledge of ISO 13485. Experience and familiarity with lab testing and automation. Good communication and interpersonal skills to be able to communicate with personnel at all levels within the organisation. Proactive, works independently and takes action in the absence of instruction. Fluent in English and Dutch.
Your new company
Mentor Medical Systems is a worldwide renowned manufacturer and supplier of medical products. The company develops, produces and sells innovative and high-quality plastic surgery products all over the world. For the past 20 years, Mentor has developed breast implants that are used in cosmetic and medical applications. Production takes place under strict laws and regulations to ensure the highest quality. Mentor has been part of Johnson & Johnson since January 2009.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 5 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary and your travel expenses are covered.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1044242