Senior Validation Engineer

Senior Validation Engineer Utilities
Alnylam was founded in 2002 on arevolutionary vision and bold mission which remain firmly in place today. Weare leading the translation of RNA interference (RNAi) into a new class ofinnovative medicines with the potential to transform the lives of people withrare genetic, cardio-metabolic, hepatic infectious, and central nervous systemdiseases with unmet need. Our first medicine, the first-ever RNAi therapeutic,has recently been approved by the FDA in the US for the treatment of thepolyneuropathy of hereditary transthyretin-mediated amyloidosis in adults andby the European Medicines Agency in the EU for the treatment of hATTRamyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition,Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have beenrecognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017and 2018- four years in a row!
The SeniorValidation Engineer role will be key in the implementation and execution of thefacilities, utilities, and process support system validation programs alignedwith regulatory expectations to ensure commercial readiness at internalmanufacturing sites. The position will be responsible for representingvalidation on project teams and ensuring completion of validation projectswithin strict timelines. The incumbent will develop strong cross functionalrelationships to ensure successful completion of facilities, utilities, andprocess support system validation efforts. The Senior Validation Engineer will lead validation activities forfacilities, utilities, and process support systems and will ensure theirmaintenance in a validated state. Therole may also require supporting internal/external audits and other lifecycleactivities to support the validation program.
Summary of Key Responsibilities
Lead validation activities for qualification of facilities,utilities, and process support systems (e.g. WFI, HVAC, cleanrooms, processgases, buffer tanks, acetonitrile system, etc.) at Alnylam's internalmanufacturing sites to establish and maintain the validated state.
Author lifecycle documents, risk assessments, and validationprotocols and reports.
Design and execute or oversee the execution of facility,utility, and support system qualification studies that are compliant withestablished procedures and aligned with industry best practices.
Coordinates with other functions and/or external vendors toensure completion of validation tasks.
Manage the development and maintenance of facility, utility,and support system validation program documents including SOPs and MasterPlans.
Provide validation support in deviation investigations andchange control.
Expected to manage complex and multiple project objectives.
May contribute in regulatory filings and inspections.
May review validation documentation or manage contractresources to accomplish defined scope of work and company goals.
Bachelor's degree in Science or Engineering with 5-8 years ofdirectly relevant validation experience in pharmaceutical, or biotechnologyindustry. Master's degree is a plus.
Comprehensive understanding of cGMP requirements forpharmaceuticals manufacturing is required
Experience in FEU validation supporting pharmaceuticalprocesses is a must. Working knowledgeof current relevant industry guidance (e.g. BPE, E2500, CFRs, EudraLex Volume4, ISPE guidance) is required.
Cleaning validation experience in a multiproduct environmentis desired
Experience with regulatory authority and external audits isdesired.
Alnylam Pharmaceuticals is an EEO employer committed to anexciting, diverse, and enriching work environment.

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