Quality Engineer II

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

We are seeking an experienced Quality Engineer II to support quality excellence across new product development, manufacturing transfer, and commercial operations. In this role, you will serve as a trusted quality partner, working cross-functionally to ensure products are developed and manufactured in accordance with quality, regulatory, and customer expectations.

You will play an important role in risk management, design controls, validation, and continuous improvement initiatives, helping teams make informed decisions that support successful product launches and reliable manufacturing performance. The ideal candidate is a proactive problem solver who thrives in a collaborative environment, takes ownership of outcomes, and is passionate about driving quality throughout the product lifecycle.

This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results in all aspects of work.

• Apply Validation Principles and Design Control processes in accordance with applicable regulatory and industry requirements (including ISO standards, ASME BPE, CE, BPOG, REACH, and others), ensuring product and process quality throughout development and commercialization.

• Support the New Product Introduction (NPI) team through the deployment of Quality Engineering tools that enable the effective development, transfer, and lifecycle management of products and processes. Partner closely with cross-functional teams to verify development deliverables and maintain Design History Files that support successful product release.

• Provide guidance and support in Design Controls and Risk Management activities for new product development and design change projects. Collaborate with Engineering, Manufacturing, and Product Development teams to proactively identify risks and drive quality-focused decision making.

• Support the completion of Risk Management activities (FMEA), Design Verification, and Process Verification efforts to ensure products and processes consistently meet quality and performance expectations.

• Assist in the development, validation, and continuous improvement of test methods that effectively evaluate product and process performance.

• Review Equipment IQ/OQ/PQ documentation in support of commercial manufacturing operations.

• Demonstrate strong organizational skills and the ability to effectively manage multiple priorities while maintaining attention to detail and a focus on execution.

• Bring a self-directed approach, exercising sound judgment, accountability, and problem-solving skills to support quality objectives and business needs.

• Participate in customer complaint investigations, partnering with stakeholders to identify root causes and implement sustainable corrective actions.

• Execute change controls and facilitate Change Control Review Board activities, ensuring effective communication, alignment, and timely decision making across impacted teams.

• Review and approve nonconformances, deviations, failure investigations, and corrective action plans, helping ensure robust solutions are implemented and sustained.

• Utilize Lean and Six Sigma methodologies to identify opportunities, improve processes, reduce risk, and support a culture of continuous improvement.

Qualifications

• Bachelor’s degree in Biological Science, Engineering, Physical Science, or a related discipline.

• Demonstrated experience in New Product Development Quality Engineering.

• Experience supporting biotech hardware, consumable products, and associated manufacturing processes.

• Working knowledge of cell culture, filtration, and chromatography operations within a bioprocessing environment.

• ASQ Certified Quality Engineer (CQE), CRE, or equivalent certification preferred.

• Minimum of 5 years of Quality Engineering experience within an ISO 9001 Quality Management System or equivalent regulated environment.

• Internal auditing experience.

• Strong communication and relationship-building skills, with the ability to effectively collaborate across technical and operational functions.

• Ability to influence outcomes, navigate complex challenges, and contribute to informed, risk-based decision making.

• Proven ability to drive results, manage competing priorities, and support continuous improvement initiatives in a fast-paced environment.

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $85,000-$115,000. Compensation decisions are dependent on several factors including, but not limited to an individual’s qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.