Senior Biological Product Safety Specialist

vor 2 Monaten

Kloten, Schweiz Envista Holdings Vollzeit

Job Description:

We are recruiting a Senior Biological Product Safety Specialist based in our Headquarter in Zurich (Switzerland) or in our Manufacturing in Karlskoga (Sweden) focusing on the correlation between manufacturing processes and final product chemical cleanliness. He/She will be responsible for translating and linking in-process and final product chemical cleanliness requirements with the necessary standards for biological safety in both validation and routine production.

The main responsibilities:

Execution pipeline and life cycles activities

  • Evaluating biocompatibility according to international standards (e.g. ISO 10993, FDA guidances) and Nobel Biocare’s processes on the entire product portfolio
  • Performing risk assessments, designing biological evaluation strategies, monitoring external testing, and issuing biological evaluation plans and reports within New Product Introduction Projects as well as for the entire life-cycle of the portfolio.
  • Subject Matter Expert in providing scientific input, justifications, rationales, and clarifications to global regulatory submissions (MDD, MDR, FDA, PMDA, NMPA etc.), marketing, product management, and other stakeholders.
  • Supporting biological product safety during internal and external audits.
  • Planning and managing the impact assessment of manufacturing, supplier, design, and material changes to medical devices to ensure product safety and sustainability.
  • Remaining up-to-date with changes in technologies, academic research, standards, and regulatory policies regarding biocompatibility.
  • Performing literature reviews and presenting the results at internal steering meetings and external events.
  • Conducting gap analyses to new standards or version changes of existing standards and guidelines; and implementing identified actions.
  • Knowledge of design control process requirements and requirements for technical documentation for medical devices.
  • Able to put together a plan for the different tasks within a project (e.g. NPI), identifying gaps and improvements.
  • Ensuring the final products meet the cleanliness specifications in regards to the level of (physical/chemical) contaminants.
  • Supporting the definition of process validation study in regards to physical/chemical cleanliness on new or updated equipment.
  • Ensuring stable product and process output for biocompatibility by supporting the definition of monitoring concepts in regards to physical/chemical cleanliness.

Process improvements, coaching, and leadership

  • Periodic review and update of procedures and templates including training.
  • Maintaining and extending a global network of external analytical partners (analysis labs, universities, research institutes) to complement and enhance internal capabilities.
  • Providing guidance to new team members.
  • Attending and learning from others' training.
  • Solving problems in challenging situations; analyzing possible solutions using technical experience.

General

  • Supporting strategy development and execution according to Envista and Nobel Biocare priorities and targets.
  • Executing all activities according to Envista’s integrity and compliance standards and programs. Showing awareness of the impact of ethical behavior by ensuring integrity in personal and organizational practices; respecting people and principles, including professional, ethical, and human values.
  • Raising and escalating potential organizational ethics and compliance issues.
  • Impacting the quality of own work and the work of others on the team; working within guidelines and policies.
  • Understanding key business drivers; using this understanding to accomplish own work.

Job Requirements:

Critical Knowledge and Qualifications:

  • Strong technical background (MSc or equivalent) in a relevant field (Biotechnology or Biomedical Engineering, Toxicology, Biology, Chemistry, or related science).
  • Understanding of ISO 10993 biocompatibility standards.
  • Broad understanding of ASTM F3127-22, ASTM F2847-17.
  • Broad understanding of manufacturing environment and process validation.
  • Understanding of ISO 13485 and ISO 14971.
  • Understanding of bone and/or mucosa biology, pharmacology, and biochemistry.
  • Fluent in English (spoken and written); German (spoken and written) is an asset.

Critical Skills/Technical Know-how:

  • A systematic and result-oriented work style.
  • Good knowledge in relevant tools (SAP, MS Office), processes (DCP and ItM), and relevant SOPs.
  • Good internal knowledge of the relevant Nobel Biocare products, their materials, manufacturing methods, and limitations.
  • Strong analytical skills.
  • Pro-active and independent working style with a strong sense of responsibility and problem-solving attitude.

Critical Experience:

  • 5+ years of relevant experience working in a regulated environment, preferably in the Dental Medical Device Industry.
  • Experience working cross-functionally and in multi-cultural teams (matrix organizations).

Operating Company: Nobel Biocare

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