Engineer III Combination Product Quality Assurance

 This role is considered Hybrid.

Overview

The Engineer III - Combination Product Quality Assurance (CPQA) is responsible for providing quality oversight for the development and life cycle management for combination products at Alnylam.   This role will work cooperatively with their counterparts throughout the combinaton product development team and QA providing quality oversight and support to ensure clinical through commercial lifecycle activities meet cGMP regulatory requirements and guidelines including Part 4 for combination products.  This position reports to the  Senior Manager of CPQA.

This position is a hybrid role and is located at the Kendall Square location in Cambridge, Massachusetts.

Key Responsibilities

• Review of post-market surveillance activities for an on-market program including device constituent and component QA support for change controls, complaints, and post-market surveillance meetings
• Provide new product and sustaining QA support for design and development activities of combination product design history, human factors, and risk management files.
• Provide quality support for notified body opinion submissions for significant changes
• Provide combination product QA support for Quality Management System (QMS) improvement efforts
• Collaborate with various CMOs and represent Alnylam QA.  Help ensure that CMOs adhere to various requirements and oversee any required manufacturing changes.
• Identify and drive process/procedure improvements to increase efficiency.  Lead and manage various QA feeder systems to ensure continued compliance.

Qualifications

• Bachelor’s degree in engineering or sciences. Advanced degree preferred
• Miminim of 3 years of relevant experience, 5 years preferred, in a regulated industry preferably with medical device, combination product, or QA experience.
• Understanding of global Device and Combination Product regulations, standards, and guidelines (e.g., 21 CFR Part 4, Part 803, Part 820, ISO 13485, ISO 14971, ISO 62366)
• Ability to translate and implement evolving regulatory requirements into internal SOPs
• Proficient technical writing skills
• Excellent organizational, communication, and interpersonal skills including collaborating and working with a high functioning team

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.