Quality Engineer II
repligen
Quality Engineer II
repligen· Repligen Corp
About this role
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.
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.
Frequently Asked Questions
What is the salary for the Quality Engineer II role at repligen?
The listed salary for this Quality Engineer II position at repligen is USD 85K–115K. This is an Full time role.
Where is the Quality Engineer II position at repligen located?
This Quality Engineer II role at repligen is based in Marlborough, MA. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Quality Engineer II role at repligen full-time or part-time?
This is listed as a Full time position. It is posted as a Quality Engineer II role in the Repligen Corp department at repligen.
Which team or department does the Quality Engineer II at repligen belong to?
This Quality Engineer II position is part of the Repligen Corp department at repligen. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Quality Engineer II position at repligen?
Click the "Apply Now" button on this page. You will be redirected to repligen's official application portal hosted on workday where you can submit your application directly.
When was the Quality Engineer II job at repligen posted?
This Quality Engineer II position at repligen was posted on Aug 3, 2026. Apply as soon as possible — early applications are often reviewed first.
Quality Engineer II
repligen · 💰 USD 85K–115K
You'll be redirected to repligen's official application page on Workday.