Philips Biological Safety Engineer – Chemistry & Chemical Engineering
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
Job Title: Biological Safety Engineer
Location: Pune
Job Id: 460475
Eligibility Criteria:
- Bachelors or Master’s Degree in Material Science, Toxicology, or Chemical Engineering with emphasis on biomaterials, polymers and organic chemistry.
- Minimum of 5+ year’s professional experience
- Lab management experience preferred
- Knowledge of biological test methods for compliance to ISO 10993 and ISO 18562 (desired).
- Familiarity with FDA 2016 Guidance Document “Use of International Standard ISO 10993-1.”
- Experience conducting biological assessments of medical devices.
- Experience documenting biological test evidence to support FDA submittals.
- Experience working with outside test labs to generate test plans and evaluate results for compliance to biological standards.
- Understanding of global medical device regulations, requirements, and standards.
In this role, you have the opportunity to be part of Philips Sleep and Respiratory Care as a Biological Safety Engineer focused on Ventilation & related accessory products. You will be responsible for implementing technical strategies, evaluating, and developing products, and providing a superior level of
technical support that benefits the organization. The position collaborates closely with Mechanical Engineers, Clinical Affairs, Marketing, Quality & Regulatory in the Ventilation business to develop and commercialize Class 2 medical devices. This position shall provide strategic direction related to the development of systems and programs for the following areas: Microbiology, Cleaning and Biocompatibility testing.You are responsible for
- Formulates and executes on biocompatibility and cleaning test plans, protocols, and reports.
- Establish effective work processes and standardized procedures that ensure compliant documentation of routine testing results and timely completion of business milestones using industry-accepted scientific principles with independent test laboratories.
- Manage and maintain vendors including supporting audits of the contract facility.
- Author and review validations and product adoptions into existing cycles.
- Perform testing and maintains documentation to support the use facility of single-use and reusable products supporting ventilation.
- Encourage continuous process improvements environment.
- Additional responsibilities may be assigned, as required, by management.
In addition,
- Work with a team to assess products for compliance to international biological standards.
- Document biological test strategies and manage testing with outside test labs.
- Document biological risk assessments and analyze results from CROs.
- Learn from and adhere to the internal quality manual (Quality System Procedures, Work Instructions, Forms).
- Maintain and update current biocompatibility Quality System Procedures, Work Instructions, and Forms.
- Develop and conduct biocompatibility training programs.
- Provide weekly project status reports.
- Prioritize project tasks to complete on schedule while maintaining the quality of work.
- Work in a team environment; peer review work.
- Work on multiple, concurrent project
Apply Online
Editors Note: Philips Biological Safety Engineer Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
