10 days old

Senior Validation Engineer

Alnylam Pharmaceuticals
Cambridge, MA 02139
  • Job Code
    TOQA2019R1032

Senior Validation Engineer

Overview

Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. In 2018, Alnylam received approval for our first product, the first-ever RNAi therapeutic, by the FDA in the U.S. for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. Headquartered in Cambridge, Mass., Alnylam employs over 1,200 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work four years in a row (2015-2018) and a Great Place to Work in the U.K. and Switzerland in 2019. Please visit www.alnylam.com for more information.

Alnylam Pharmaceuticals is seeking an experienced validation professional to join a rapidly growing Technical Operations Organization. This role will be key in supporting the validation activities at our contract manufacturing sites aligned with regulatory expectations as we transition from a Research and Development Organization to a Commercial Organization. The successful candidate's primary role will be to oversee process and cleaning validation projects for our future Commercial Products. The position will entail building strong cross-functional relationships throughout the organization and translating multiple assumptions into a balanced validation plan.

Summary of Key Responsibilities

  • Partnering with CMO and ensuring validation activities (equipment, cleaning and process) are conducted per Alnylam requirements
  • Experience in GMP drug substance manufacturing and/or drug product formulation/filling operational environment is a must.
  • Provide support for Validation Lifecyle Management activities to maintain the validated state (CPV, requalification).
  • Building relationships with partner CMO and auditing the validation status of processes
  • Develop and maintain validation program documents including SOPs and Master Plans.
  • Design and execute process and cleaning validation studies at company sites that are technically sound, compliant with established procedures and aligned with industry best practices.
  • Provide validation support in deviation investigations and change control.
  • Expected to manage complex and multiple project objectives independently.
  • Expected to contribute in audits and inspections from regulatory agencies
  • Can be asked to help in other areas of validation efforts like shipping, packaging and labeling etc. when needed.

Qualifications
  • Bachelor's degree in Science or Engineering and 8-10 years of operational validation/manufacturing experience in pharmaceutical, or biotechnology industry. OR
  • Master's degree in Science or Engineering with 6-8 years of operational validation experience/manufacturing in pharmaceutical, or biotechnology industry.
  • Experience in equipment and/or cleaning validation is preferable.
  • Experience in manufacturing and process development is a plus.
  • Expected Travel 15-20%

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

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Posted: 2019-10-10 Expires: 2019-11-08
Sponsored by:
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Sponsored by:
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Senior Validation Engineer

Alnylam Pharmaceuticals
Cambridge, MA 02139

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