Microbiologist (7-10 yrs)
- Responsible for handling of microbiology lab & simulated reprocessing (cleaning and sterilization -instruments life test) projects.
- Perform qualification and validation of microbiological methods and equipment(s).
- Cleaning(with protein, hemoglobin, and other biochemical markers), disinfectant and sterilization validation of medical devices.
- Performs BI (Biological Indicator), Microbial limit test, growth promotion testing, environment monitoring, water testing and other general microbiological tests required for incoming, intermediate and finish sterile products.
- Apply GLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to sterilization, cleaning, disinfection, bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of medical devices.
- Support team members to create or improve procedures, policies, processes, systems, and technology requirements.
- Independently lead and timely execution of complete project deliverables. Hold self-accountable to deliver on tasks & meet business deadlines.
- Mentor, influence and Support team on design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
- Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
- Audits/ NC CAPA/ Deviations/ change control/ Procedures improvements/ risk evaluations and data/ record/ report reviews
- Assess new and or required test technologies and capabilities for the organization.
- Deliver high quality results with passion, energy, and drive to meet business priorities. Mentor, develop and influence across the business, intentionally building divisional relationships.
What you will need :
- M.Sc./ B tech/ M tech Microbiology, Biotechnology, Bioengineering, Biopharma
- Worked with different regulatory bodies (USFDA, EU, PMDA, MHRA etc) in production requirements of medical devices/pharma etc
Experience: Min 5 years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
- Strong Instrument Working Knowledge used in microbiology and analytical laboratories.
- Possess an in-depth knowledge of the industry and competitive landscape, ensure effective implementation, and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 17025, ISO 14971 throughout the design and development process various test requirements.
- Expert with extensive experience applying industry standards for device development and Verification/ validation testing.
- Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques. Moist heat is preferred.
- Ability to use different standards like ISO, AAMI, USP, ANSI, EPA, EU for testing and related guidelines toward the design, manufacturing, development, and launch of initiatives in medical/ pharma.
- Ability to effectively work cross-functionally with Product Development, Operations and Marketing.
- Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
- Demonstrated ability to technically mentor associate engineers and scientists in work field.
- Demonstrated ability to prioritize tasks in a deadline-driven environment and to communicate complex plans and technical information to team members
- Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
- Demonstrated organizational and written/verbal communication skills.
- Demonstrated ability to self-motivate, effectively work with others in various coordinate disciplines and on multi-national teams.
- Demonstrated knowledge about a variety of microbiological and chemistry-based concepts, practices, and procedures and competency in advanced testing technologies