Senior Biological Product Safety Specialist – Cleanliness expert

Job Description:

We are recruiting 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 the responsible in 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
• Performs risk assessments, designs biological evaluation strategies, monitor external testing and issue biological evaluation plans and reports within New Product Introduction Projects as well as for the entire life-cycle of the entire portfolio of Nobel Biocare.
• Subject Manager 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
• Supports biological product safety during internal and external audits
• Plan and manage the impact assessment of manufacturing, supplier, design and material changes to medical devices to ensure product safety and sustainability.
• Remains up-to-date with changes in technologies, academic research, standards and regulatory policies regarding biocompatibility
• Performs literature review and presents the results at internal steering meetings and external events
• Performs gap analyses to new standards or version changes of existing standards and guidelines; and implement 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 ), identify gaps and improvements
• Ensure the final products met the cleanliness specifications in regards to level of (physical/chemical) contaminants
• Support in the definition of process validation study in regards to physical/chemical cleanliness on new or updated Equipment
• Ensure 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
• Maintains and extends a global network of external analytical partners (Analysis labs, Universities, research Institutes) in order to complement and enhance internal capabilities.
• Provides guidance to new team members.
• Attends and learns from others trainings.
• Solves problems in challenging situations; analyzes possible solutions using technical experience

General

• Support strategy development and execution according to Envista and Nobel Biocare priorities and targets.
• Execute all activities according to Envista’s integrity and compliance standards and programs. Show awareness of impact of ethical behavior by ensuring integrity in personal and organizational practices; respects people and principles, including professional, ethical and human values.
• Raises and escalates potential organizational ethics and compliance issues.
• Impacts quality of own work and the work of others on the team; works within guidelines and policies.
• Understands key business drivers; uses this understanding to accomplish own work

#LI-LN1

Job Requirements:

Critical Knowledge and Qualifications:

• Strong technical background (MSc or equivalent) in 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 working attitude

Critical Experience:

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

Operating Company:

Nobel Biocare

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.