29 days old

Senior Validation Engineer

Alnylam Pharmaceuticals
Cambridge, MA 02139
  • Job Code
    200021

Senior Engineer - Validation

Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are a growing biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers.

VISION: Harnessing a revolution in biology for human health

MISSION: Build a top-tier biopharmaceutical company founded on RNAi

CORE VALUES: Commitment to People, Innovation & Discovery, Sense of Urgency, Open Culture, and Passion for Excellence

Overview:

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:

  • Partner with CMO and ensure 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).
  • Build relationships with partner CMO and audit the validation status of systems and 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 is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015 and 2016. Our commitment to innovation, excellence and our people is reflected in everything we do. We come together from dozens of countries. We have diverse educations, backgrounds, skill sets, lives, and turns of phrase. We listen. We laugh. We know what to take seriously. We work incredibly hard. We do many things at a time, but have a resolute focus on creating innovative medicines.

In January 2015, we announced our "Alnylam 2020" guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline.

Alnylam offers a superior benefits package to meet the varied personal and workplace needs of our employees. These benefits reflect our commitment to foster a culture of caring, and to enable our employees to achieve success at home and at work.





Posted: 2020-12-22 Expires: 2021-01-20
Sponsored by:
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Sponsored by:
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Senior Validation Engineer

Alnylam Pharmaceuticals
Cambridge, MA 02139

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