Senior Process Engineer

Alnylam Pharmaceuticals • Norton, MA

3d • $129,000 - $174,600 • Onsite

About The Position

The Senior Process Engineer will support R&D, CMC, GMP & non-GMP operations, CMO/CDMO operations, including new construction and upgrades to existing facilities, infrastructure, systems and equipment/instruments. The role will be responsible for troubleshooting, resolving issues and engineering support as required to design, install, commission and validate equipment and systems.
This position is onsite and will be primarily located at 20 Commerce Way, Norton, MA. Participation in 24x7 on call engineering service to operational sites (on rotation with other team members) in a requirement of this role.

Requirements

• Bachelor’s degree in Chemical Engineering or related technical field
• 6+ years of relevant work experience - including design, capital projects, and operations support for the biopharmaceutical industry.
• Knowledge of biopharmaceutical processes, including oligonucleotide synthesis, chromatography, ultrafiltration systems, evaporation systems, and solvent handling/distribution systems.
• Knowledge of GMP process utility systems including high purity water (WFI), CIP, process waste, etc.
• Excellent troubleshooting skills; ability to react quickly to understand and solve problems
• Strong understanding of GMPs and good engineering practice (GEP), including industry standards and guidelines, such as, ASME BPE, ISPE Baseline Guides, CFR’s, OSHA, ISA S88, GAMP, ASTM E2500, etc.

Responsibilities

• Independently lead assigned engineering projects as well as support moderate to large sized engineering projects. This includes process and equipment design, project management, and project engineering.
• Drive projects to completion to meet quality, timeline and budget objectives.
• Manage all assigned equipment design, procurement and startup, including specification development, procurement activities, FAT/SAT, installation, commissioning, debugging, optimization and validation support.
• Support development laboratories and manufacturing operations including optimization and troubleshooting of operational issues in manufacturing, equipment, maintenance, validation, or capital projects.
• Provide technical engineering support and ownership for investigations, deviations and CAPAs. Additionally, provide inspection support including inspection-readiness and response assistance, where applicable.
• Develop, evaluate, and implement cost-effective equipment, facility and utility engineering solutions
• Support enhancements / development of engineering documentation, technical standards, guidelines, and procedures in accordance with industry best practices
• Promote a culture of safe and compliant design and operation
• Support process and automation system designs and project lifecycle activities

Benefits

• Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
• Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

What This Job Offers

• Job Type: Full-time
• Career Level: Senior