At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets.
Responsibilities:
- Execute the verification and validation activities for drug delivery systems.
- Participate and provide inputs for resource planning, scheduling and overall execution of verification and validation activities
- Provide support for setting up the testing infrastructure, test benches, jigs and fixtures for testing of electro-mechanical drug delivery systems.
- Work closely with different systems engineering & sub-systems team (mechanical & electronics) to understand overall system level architecture, interaction between different sub-systems, identify critical safety and quality characteristics to develop test plan & protocols
- Execute verification of prototypes, pilot batch, feasibility runs for drug delivery systems as per the plan
- Work closely with manufacturing, quality control and assurance teams to develop consistent test methodologies, transfer to test specifications and adopt best practices for verification and validation activities
Skills & Experience:
- A minimum of 4 years of experience in medical device design and development.
- 3+ years of experience in Medical Devices / Systems Verification and Validation activities
- Hands-on skills with the proven ability to independently apply deep technical knowledge in verification and testing of complex drug delivery devices/systems
- Required to have knowledge in product lifecycle i.e. from product conceptualization to design development and manufacturing of medical devices
- Design & development skills for jigs & fixtures required for Verification of medical systems & devices
- Broad understanding of general manufacturing processes like injection molding, machining, electronics and assembly processes.
- Hands-on Experience in engineering Lab Management & calibration activities
- Has knowledge & understanding of medical device regulations like ISO13485, EU MDD & US FDA 21 CFR 820 & standards requirements like IEC60601, ISO14971, IEC62304 etc..
- Possess a high level of integrity with a passion to work with entrepreneurial teams in a rapidly growing organization
- Excellent written and verbal communication
- Strong presentation & documentation skills