SCHOTT is a leading international technology group in the areas of specialty glass and glass-ceramics. With more than 130 years of outstanding development, materials and technology expertise we offer a broad portfolio of high-quality products and intelligent solutions. SCHOTT is an innovative enabler for many industries, including the home appliance, pharmaceutical, electronics, optics, life sciences, automotive and aviation industries. SCHOTT strives to play an important part of everyone’s life and is committed to innovation and sustainable success. The parent company, SCHOTT AG, has its headquarters in Mainz (Germany) and is solely owned by the Carl Zeiss Foundation. As a foundation company, SCHOTT assumes special responsibility for its employees, society and the environment.
Task:
About us
Our Business Unit Pharmaceutical Systems is one of the world’s leading manufacturers of drug containment solutions and delivery systems for injectable drugs. More than 600 production lines in 14 countries worldwide produce more than 10 billion syringes, vials, ampoules, cartridges and special articles of tubing glass or polymer.Your Contribution
Environmental Monitoring
Implementation and provision of monitoring activities for clean rooms, technological media and products in accordance with the provisions of relevant guidelinesProvision of basic data for environmental monitoring reportsParticipation in the monitoring and processing of deviations occurring in the scope of responsibility (initiation of CAPA for OOS & deviations in clean/ controlled areas), as well as in supporting CAPA measures and investigations in cooperation with other departmentsParticipation or lead investigations for OOS and deviationsOrder nutrient mediaHygiene concept: participation in monitoring of the implementation of the hygiene concept at the siteOrganization: general laboratory organization and administration (e.g. inventory management, orders, ensuring the calibration status of the devices used)Management the pest control process, keeping contact with external company, review external reports and initiates CAPAs as per the internal process/ limitsResponsible for the light intensity measurements, planning of external measures, address local actions if needed
Clean & controlled room qualification
Participation in the qualification and validation processes of the infrastucture (clean room, controlled area, WFI, compressed air), responsible for the control and compliance with the required standardsParticipation in the validation of microbiological process and test methods, preparation of reportsPreparation/ support of URS of clean/ controlled rooms
GMP concept & training
Participation in the implementation/ establishment and maintenance of the hygiene concept, its monitoring, dress code and clothing requirements and implementation of clean room checkInitial GMP training for new employees (if necessary)Support assessments, projects and developments with knowledge/ experience of GMPFollow GMP and GDP rules and make others keep the rules; support the employees with training and technical instructions in consultation with their supervisors
Projects & developments
Support of process and product development through preparing risk analyzes related to bioburden, endotoxins and particle measurements, as weel as during sterilization processes and procedures
Your ProfileBSc in natural science, microbiology, chemistry or biologyMin. 2 years of experience in microbiological laboratory and clean room environmentExperience in environmental monitoringExperience in bioburden testKnowledge of ISO 15378/ ISO 13485 / ISO 14644 standard, GMPGood command of EnglishProblem solving skills (OOS & deviation management)
Your Benefits
SCHOTT’s openness to promote your further development is just as great as our additional benefits. Ranging from active health management via flexible working hours and hybrid work all the way to corporate pension plans: everything geared to suit your goals and needs. Discover a special corporate culture where everyone has the opportunity to develop their entire potential.
At SCHOTT, you can expect a unique corporate culture where we emphasize equity, diversity, and inclusion. We know: motivated and committed employees are the precondition for the success of our company.
Flexible working hours; Further training and education; Multiple career opportunities; Talent developmentPlease feel free to contact us
You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future. Do you want to be successful with us? Then, please send us your application: SCHOTT Hungary Kft., Human Resources, Ilona Mosonyi+3694568484
At SCHOTT, it’s your personality that counts – not your gender, your identity, or origin.