Manufacturing Engineer I

This role is considered On-Site.

Overview

The Manufacturing Engineer will be primarily responsible for technical, project, and GMP support across drug substance manufacturing at Alnylam's Norton, Massachusetts manufacturing site.

Key Responsibilities

• Complete training assignments on time.
• Report safety incidents in EHS system within 24 hours. Participate in implementation of CAPA associated with safety incident investigations and ensure timely closure.
• Work in a matrixed environment of engineering and scientific professionals to provide technical, project, and GMP support for oligonucleotide drug substance manufacturing.
• Perform "end user" Manufacturing review & approval of equipment life cycle documents (DQ, URS, FS, CS, etc. ), engineering test plans, and validation protocols / reports.
• Perform Manufacturing impact assessment and change action creation for change controls (in consultation with Manufacturing team's SMEs and SOP / MBR owners).
• Support manufacturing deliverables for New Product Introductions, including generation of mass balance, bill of materials, and process fit analysis.
• Support deviations / investigations, CAPA's, and implementation of process & equipment related change controls.
• Identify and support implementation of continuous improvement projects to reduce cycle time, reduce COGS, and / or increase robustness.
• Other duties as assigned

Qualifications

Bachelors of Sciences (BS) degree in engineering or chemistry (BS) with 0-3 years of relevant experience in a regulated GMP facility.

Minimum requirements may be substituted for the equivalent combination of education and / or experience in the industry.

• Basic knowledge of cGXP requirements for pharmaceutical manufacturing and commercial / clinical supply required.
• Must be able to work in cleanroom environment as needed.
• Potential to travel occasionally to participate in factory acceptance testing (FAT) for new equipment.
• Previous experience with small molecule / oligonucleotides is desired, but not required.
• Experience with GE / Cytiva Unicorn software is desired, but not required.
• High level of attention to detail is required.
• Must possess excellent English communication skills.
• Strong organization and time management skills and ability to work independently as well as in a team setting are required.
• Ability to interact with department management and cross-functional stakeholders is required.

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,Alnylamhas led theRNAi Revolutionand continues to turn scientific possibility into reality.

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 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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.

Alnylam is an E-Verify employer.

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 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.