Job title: Staff Engineer – Lab (Biochemistry)
Job description: Work Flexibility: Not available
What you will do:
- Responsible for handling of cleaning validation capability at lab (cleaning validations with protein, hemoglobin, and other biochemical markers) and support in future material characterization capability.
- Perform and support team for testing for cleaning validations, material characterization and related fields.
- Perform qualification and validation of Bio-analytical methods and equipment(s). Manage consumables and equipment purchase required for testing and capability.
- Time plan and strategy construction and work with different stakeholders for test and capability building.
- Leading efforts for Chemical characterization, composition of medical devices and understanding the biocompatibility and mechanical properties.
- Apply GLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines cleaning, disinfection, 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. Work with team, technicians/ support staff and team on projects and capability.
- 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 need:
- M.Sc./ B.Tech/ M.Tech – in Analytical Chemistry, Biochemistry, Biotechnology, Bioengineering, Pharma, Microbiology with work experience: 10 -12 years
- Min 7 years of experience specializing in analytical chemistry, medical devices or pharmaceutical microbiological or biological/ biochemistry testing, research, and development experience.
- Strong Instrument working knowledge with results analysis on equipment/ instruments used in chemical and analytical laboratories such as TOC (Total Organic Carbon) analyzer, Spectrophotometer, HPLA, GC, GCMS, LCMS, AAS, ICP-OES/ ICPMS, DSC, TGA, FTIR, Steam sterilizer, Washer disinfector etc.
- 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 and material characterization.
Good to have:
- Worked with different regulatory bodies (USFDA, EU, PMDA, MHRA etc) in production requirements of medical devices/pharma etc.
- 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.
- Experience in medical device, pharmaceutical Quality management system and risk analysis tools and techniques.
- 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.
Travel Percentage: 10%
Location: Gurgaon, Haryana
Job date: Sat, 19 Mar 2022 02:13:38 GMT
Apply for the job now!