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Senior Process Engineer

As a member of Alnylam's growing engineering team, the senior process and utilities engineer will support the development of a new, state of the art oligonucleotide facility that will be the first commercial drug substance facility for Alnylam in Norton MA.  The position will play a critical role as the Engineering lead/representative for a specific area of the process/project.  Occasional support may be required at other sites located at the 665 Concord Ave, Cambridge (Alewife Manufacturing Facility) and corporate headquarters in Kendall Square Cambridge, MA. Summary of Key Responsibilities Provide technical leadership for capital projects and operational responsibility post implementation, including 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 Develop, evaluate and implement cost-effective equipment, facility and utility engineering solutions Support drug substance manufacturing operations, including troubleshooting of operational issues in manufacturing, maintenance, validation, or capital projects Develop process engineering capabilities, including development of technical standards, guidelines, and procedures in accordance with industry best practices Promote a culture of safe and compliant design and operation Lead cross functional teams capable of supporting ongoing operations, validation activities, and large & small capital projects Serve as technical process engineering leader for capital projects, interfacing with both Alnylam stakeholders and external consultants / contractors Review and critique process and automation system designs and support project lifecycle activities in alignment with an ASTM E2500 model Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations Lead equipment issue identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA)Lead efforts with manufacturing, process development, facilities, QA, and other stakeholders in developing requirements and recommendations for system modifications Manage, review, and update engineering documentation for new capital projects and existing infrastructure, including P&IDs, specifications, and other technical documents Support development of SOPs for process equipment and operations Support execution of CQV protocols Author / Review appropriate equipment specifications Develop and manage relationships with vendors, suppliers, and contractors To support all process equipment related activities at Alnylam Alewife and Norton manufacturing sites, as well as Process Science labs in Cambridge. Responsible for the development and maintenance of lifecycle deliverables for equipment and systems. Management of small/large projects with a coordination across multi-disciplines and potentially multiple vendors. Perform other duties as needed  Qualifications Bachelor's degree in Chemical Engineering, Mechanical Engineering or related technical field 8+ years of relevant work experience - including operations support for the biopharmaceutical industry.  Capital projects, design, and green field experience desirable.  Knowledge of GMP process utility systems including high purity water (WFI), CIP, nitrogen, process air, process waste, etc. Knowledge of bulk solvent storage and distribution systems Strong understanding of GMPs (CFR, EudraLex) and good engineering practice (GEP), ASME BPE, ASTM E2500, ISPE guidance, etc. Experience starting up, debugging and optimizing equipment operation Experience developing documentation including P&IDs, specifications, protocols, and SOPs Demonstrated ability to work in a GMP manufacturing environment Excellent organizational, verbal and written communication skills and be able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance. Strong project management skills. Strong process design and construction management from installation to system turnover experience The ability to work at all Alnylam Massachusetts site locations/facilities. Carry a mobile phone/ device Valid driver's license Ability to provide rotating 24x7 on-call technical support of Automation systems for ongoing operations Ability to lift 50 lbs. Ability to travel 10% Ability to provide field support in construction, CQV, and manufacturing operations  Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. TOQA20191004
Salary Range: NA
Minimum Qualification
8 - 10 years

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