Bioprocess Quality Engineer II: Drive Launch & Quality Excellence

Repligen Corporation; Marlborough (MA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Variable compensation program

Equity potential

Paid time off

Health/dental/vision benefits

Retirement benefits (401k)

Job summary

Repligen Corporation is seeking an experienced Quality Engineer II to drive quality excellence across development, transfer, and commercial operations. You will partner cross-functionally to ensure products meet quality, regulatory, and customer expectations throughout the lifecycle.

The role emphasizes risk management, design controls, validation, and continuous improvement, with a proactive, collaborative approach and ownership mindset.

Qualifications

• Bachelor's degree in Biological Science, Engineering, Physical Science or related discipline.
• 5+ years of Quality Engineering experience in ISO 9001 or equivalent.
• Experience with biotech hardware, consumables and manufacturing processes.
• Auditing experience and knowledge of design controls and risk management.

Responsibilities

• Apply validation principles and design controls per regulatory requirements.
• Support NPI with quality engineering tools and DHF maintenance.
• Provide guidance in design controls and risk management across projects.
• Support Risk Management, FMEA, and Verification activities.
• Assist in test method development and process validation.
• Review IQ/OQ/PQ documentation for manufacturing operations.
• Lead change controls and Change Control Board activities.
• Review nonconformances and CAPA plans to ensure lasting solutions.
• Utilize Lean and Six Sigma to drive process improvements.

Skills

Quality Engineering

ISO 9001

Auditing

Cross-functional collaboration

Lean Six Sigma

Education

Bachelor's degree in Biological Science, Engineering, Physical Science, or related discipline

CQE/CRE certification preferred

Tools

FMEA

IQ/OQ/PQ documentation

Job description

Repligen Corporation is seeking an experienced Quality Engineer II to drive quality excellence across development, transfer, and commercial operations. You will partner cross-functionally to ensure products meet quality, regulatory, and customer expectations throughout the lifecycle.

The role emphasizes risk management, design controls, validation, and continuous improvement, with a proactive, collaborative approach and ownership mindset.