Biotech Quality Engineer II: NPI & Process Excellence

RepliGen Corporation; Town of Marlborough (NY); On-site; USD 85,000 - 115,000; Full time

Job summary

RepliGen Corporation is seeking an experienced Quality Engineer II to drive quality excellence across NPD, transfer, and commercial operations. You will partner with cross-functional teams to ensure products are developed and manufactured to quality, regulatory, and customer expectations.

The role emphasizes risk management, design controls, validation, and continuous improvement, with ownership of change controls, design history files, and robust problem solving to support safe, reliable

Qualifications

• Bachelor’s degree in Biological Science, Engineering, or related discipline.
• 5+ years of Quality Engineering in ISO 9001 or equivalent.
• Experience with biotech hardware and manufacturing processes.
• Knowledge of cell culture, filtration, and chromatography in bioprocessing.
• ASQ CQE or CRE certification preferred.
• Internal auditing experience.
• Strong communication and cross-functional collaboration.
• Ability to drive risk-based decisions and continuous improvement.

Responsibilities

• Apply Validation Principles and Design Controls per regulatory/industry requirements.
• Support NPI with Quality Engineering tools and maintain Design History Files.
• Provide guidance in Design Controls and Risk Management for new product development and design changes.
• Support Risk Management activities (FMEA), and Verification/Validation efforts.
• Assist in development, validation, and continuous improvement of test methods.
• Review IQ/OQ/PQ documentation for commercial manufacturing operations.
• Demonstrate organizational skills and manage multiple priorities with attention to detail.
• Lead change controls and facilitate Change Control Board activities.
• Participate in customer complaint investigations and implement corrective actions.
• Utilize Lean and Six Sigma to drive continuous improvement.

Skills

Quality Engineering

New Product Development

Risk Management

Design Controls

Internal Auditing

Regulatory Compliance

Cross-functional Collaboration

Leadership

Education

Bachelor’s degree in Biological Science, Engineering, Physical Science

ASQ CQE / CRE certification

Tools

IQ/OQ/PQ documentation

Design History Files

Process Validation

Job description

RepliGen Corporation is seeking an experienced Quality Engineer II to drive quality excellence across NPD, transfer, and commercial operations. You will partner with cross-functional teams to ensure products are developed and manufactured to quality, regulatory, and customer expectations.

The role emphasizes risk management, design controls, validation, and continuous improvement, with ownership of change controls, design history files, and robust problem solving to support safe, reliable