Audit-Jobs in Deutschland

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

As Team Lead you will have dual responsibilities of both 1) maintenance of a team of microbiologists and microbiology laboratory in Hechingen, and 2) coordinating the R&D Sterility Assurance and Microbial Sciences (SAMS) sterilization activities for the sites Hechingen and Castlebar. Activities will include development of a laboratory team, maintenance of the Microbiology Laboratory, and coordinating of sterilization work assigned to either Hechingen or Castlebar facilities. This role will report to the Assistant Director of Sterility Assurance and Microbial Sciences supporting Research and Development testing for the Vantive product portfolio.

• Responsibility for the personnel and operations of the Hechingen R&D Microbiology Laboratories
• Development and qualification of laboratory equipment and processes as well as the associated documentation
• Test drug products and medical devices, including new product development, test method development & validation and investigations (including manufacturing support)
• Work with product development teams, product design owners, contract testing laboratories and manufacturing QA/QC laboratory personnel to complete required tasks
• Safe work practices of all personnel working in the Hechingen R&D Microbiology Laboratory
• Managing laboratory resources to deliver on time test results
• Constructing detailed, accurate schedules, interfacing with development, technical and manufacturing groups, leading teams through the planning and execution of work
• Assure laboratory and documentation is audit ready and team can effectively response to auditor inquiries
• Assure appropriate investigations are conducted on laboratory failures and out of specifications
• Supporting R&D project through laboratory testing and/or the use of existing data to support products
• Working with other SAMS laboratories to coordinate testing and other activities in support of R&D projects
• Devising new approaches to complex problems through adaptations and modifications of standard technical principles
• Assure the use of appropriate standards in laboratory testing
• Assuring all work complies with Vantives’s Quality system and cGDP/cGMP practices.
• Responsibility for the development and qualification of sterilization processes for medical devices and pharmaceutical products
• Provide input on the sterility assurance and microbial control for new product development as well as the sustaining of existing marketed products
• Work with product development teams, product design owners, laboratory and manufacturing personnel to complete required tasks
• Provide regular updates to Sterility Assurance and Microbial Sciences management

• Degree in Chemical Engineering, Mechanical Engineering, Microbiology or related discipline and 3-5 years related work experience
• Strong Engineering or Microbiology background and experience
• Demonstrated ability to lead a team, including ability to train and develop personnel
• Experience managing multiple simultaneous projects and work activities
• Knowledge of medical device and/or pharmaceutical industry
• Knowledge of GDP/GMP/GLP practices
• Ideally experience in methods, including: Statistics and Statistical Software, Moist Heat Sterilization, Radiation Sterilization, Ethylene Oxide Sterilization, Sterilization Qualifications, Bioburden or Sterility testing, Sterile barrier / Container Closure Integrity (CCI)
• Pharmaceutical or Medical Device manufacturing experience is desirable
• Experience participating in professional and/or standards organizations
• Excellent English and good German language skills

If you like the sound of the above role, can thrive in a fast-paced working environment and are excited about working in a learning and growth culture, then we’d love to talk to you. Apply direct on our Online System.

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