Filling Engineer
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
Roles & Responsibilities
Engineering Project Support and Operation Readiness:
Participate in new facility design and construction including but not limited to process design FAT SAT IOPQ smoke study VHP Isolator EMPQ APS etc. to contribute to project delivery.
Support the initial development and optimization of aseptic filling processes.
Participate in the implementation of operation readiness eg: draft equipment operation procedures and logbook 5S machine cleaning according to readiness plan.
Trained and qualified on equipment operation and aseptic techniques.
Perform other duties as assigned.
Routine Operation:
Ensure routine operation in compliance with Roches GMP/SHE and regulation requirements.
Performing the following tasks: e.g. vial washing filling and stoppering capping.
Train new employees and enhance the professional capabilities of the team.
Support environmental monitoring activities to ensure that the Isolatore environment meets aseptic standards.
Handle deviations during production and implement CAPA.
Diagnose and resolve equipment malfunctions promptly with the support of maintenance engineers to minimize downtime.
Execute regular validation activities such as APS.
Ensure data accuracy integrity and traceability for the activities in the GMP area.
Related IT system operations such as SAP MES Veeva Cornerstone.
Perform other duties as assigned.
Qualification and Experience
Education/Qualifications
Colleges Degree (Pharmaceutical / Biological is preferred) and above.
Job Required Competencies
5 or more years operation experience in the injection pharmaceutical industry MNC Bio-pharma preferred.
Experienced in strategic projects of Aseptic Filling facility including design commissioning & qualificationIsolator filling line is preferred.
Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry especially in the biological industry.
Fluent communications skills in English is preferred and the ability to effectively communicate collaborate and foster positive interactions with team members and stakeholders.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Key Skills
- ASP.NET
- Health Education
- Fashion Designing
- Fiber
- Investigation
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
