Device Validation and Verification Specialist

4 days ago

Bengaluru, Karnataka, India Biocon Biologics Full time

At Biocon Biologics, we are pioneering a new era in healthcare innovation. Our commitment to creating high-quality, affordable biosimilars has positioned us at the forefront of the biosimilars revolution.

About Us

We believe that patients come first and our culture is centered around fostering a purpose-driven work environment where employees have the passion and autonomy to drive change. With proven end-to-end expertise in the field of biosimilars, from development to commercialization, we strive to impact a billion lives worldwide.

We are seeking an experienced Device Validation and Verification Specialist to join our multicultural global team. As a key member of our Design Quality function, you will play a critical role in ensuring device development projects meet regulatory requirements.

Responsibilities
  • Represent the Design Quality function on device development project teams and collaborate with multiple departments, including R&D, Quality Control, Manufacturing, and Regulatory Affairs.
  • Ensure device development projects comply with FDA 21 CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
  • Contribute to design and manufacturing documentation, including material specifications, drawings, inspection procedures, and manufacturing procedures.
  • Lead or support design activities, such as design verification, validation, test procedure development, usability engineering, and risk management.
  • Set up testing infrastructure, test benches, jigs, and fixtures for mechanical and electro-mechanical Drug Delivery System testing.
  • Plan and execute verification of prototypes, pilot batches, and feasibility runs for Drug Delivery System.
  • Apply statistical methods with appropriate risk-based justification.
  • Promote continuous improvement in design control activities and quality tool usage within the design team.

This role requires strong knowledge of quality regulations, including 21 CFR Part 820, ISO 13485, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366, and ANSI HE75.

About the Role

The ideal candidate will possess hands-on experience in Design History File compilation, technical file documentation, internal and external inspections, and regulatory audits. Experience with process improvements, qualification, and validation is also essential. We are looking for a skilled professional with a strong background in device development and validation, who can communicate effectively with cross-functional teams.

What We Offer

As a Device Validation and Verification Specialist at Biocon Biologics, you can expect:

  • A competitive salary range: $90,000 - $120,000 per annum (depending on location and experience).
  • A dynamic and multicultural work environment.
  • Ongoing training and development opportunities.
  • Collaborative teams working towards a shared vision.

If you are a motivated and detail-oriented professional with a passion for medical device validation and verification, please submit your application for this exciting opportunity to join our team.

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