Senior Validation Engineer - Process Equipment

Senior Validation Engineer, Process Equipment
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 theequipment validation and cleaning validation programs aligned with regulatoryexpectations to ensure commercial readiness at internal manufacturing sites.The position will be responsible for representing validation on project teamsand ensuring completion of validation projects within strict timelines. Theincumbent will develop strong cross functional relationships to ensuresuccessful completion of facility, equipment and utility validation and cleaningvalidation efforts. The SeniorValidation Engineer will lead validation activities for equipment and cleaningand will ensure their maintenance in a validated state. The role may also require supportinginternal/external audits and other lifecycle activities to support thevalidation program.
Summary of Key Responsibilities
Lead validation activities for qualification and cleaning ofmanufacturing process equipment (e.g. CIP, chromatography skids,oligonucleotide synthesizer, Ultrafiltration skids, 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 equipmentqualification and cleaning validation 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 equipment andcleaning validation program documents including SOPs and Master Plans.
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.
Experience with process equipment related to oligomanufacturing in a multiproduct facility is a plus.
Alnylam Pharmaceuticals is an EEO employer committed to anexciting, diverse, and enriching work environment.

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