Manufacturing Technician II (Norton, MA) - 2nd Shift

This role is considered On-Site.

Overview

With direct supervision, this individual will perform routine GMP manufacturing operations at the Norton Manufacturing Facility, ensuring safe, efficient and cGMP-compliant operations at all times.

Responsibilities include but are not limited to operation of production equipment in the areas of weigh / dispense, solution preparation, equipment CIP / COP and small parts cleaning, ultrafiltration, HPLC, chemical synthesis and materials stocking in manufacturing suites.

Operates production equipment according to SOPs for the production of clinical products. Requires interaction with support groups (Facilities, QC, QA) to ensure accurate documentation of activities.

Key Responsibilities

• Carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP) and Batch Records.
• Escalate process related issues and interact with support groups to ensure timely resolution in compliance with cGMPs, EHS and corporate policies.
• Complete documentation clearly, accurately and at the time of performing the activity to conform to cGMP standards.
• Complete training assignments on time.
• Report safety incidents in the EHS system within 24 hours.
• Report deviations / potential deviations to Supervisor by end of shift.
• Complete equipment / room use logbook requests, reviews and submission for archiving.
• Propose and perform documentation revisions.
• Execute materials Goods issue transactions in SAP
• Carry out work in a safe manner, notifying management of safety issues and risks.
• Identify and support implementation of continuous improvement projects.
• Become qualified trainer for at least 3 unit operation areas (such as buffer prep, amidite prep, UF, vessel cleaning-out-of-place (COP), etc.).
• Serve as unit operation owner for at least 1 unit operation area.

Qualifications

• Must possess a mechanical and scientific aptitude and be able to clearly and thoroughly document all work on existing forms and records.
• Minimum Biotech Certificate / Associates of Science (AS) degree (Bachelors of Science preferred) with a minimum of 1-2 years' experience in a regulated GMP facility.

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

• Safety and the ability to maintain a compliant, highly effective and efficient product environment are critical.
• High level of attention to details in both operations and documentation is required.
• Must be able to execute strenuous, sometimes repetitive physical work on manufacturing shift schedule in classified cleanroom environment.

Ability to lift objects up to 50 lbs, and push / pull objects including bulk materials up to 250 lbs with assistance.

• Ability to wear half face and full-face respirators / PAPR as required for chemical processing.
• Must possess excellent communication skills, with prior experience training peers preferred.
• Strong time management skills, attention to detail, and an ability to work in a team setting 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, 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.