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Pfizer

Makes cancer drugs, vaccines and other medicines

Principal Validation Engineer

Regulatory & Quality (Life Sciences)Posted on Oct 30
Full-timeAndover, MA, USA

About the Job

Requirements

  • A bachelor's degree in Science or Engineering and at least 6 years of experience, an MBA or master's degree and at least 5 years of experience, a PhD or JD and at least 1 year of experience, or an MD or DVM with any years of relevant experience.
  • Experience in the pharmaceutical, biopharmaceutical, or biotechnology industry.
  • Experience or broad knowledge in biopharmaceutical development, manufacturing, and lifecycle management.
  • Experience in project management and leading complex projects.
  • Effective written and verbal communication skills.
  • Strong interpersonal skills and ability to collaborate in a team environment across business functions.
  • Ability to perform mathematical calculations, scientific computation, and complex data analysis.
  • Occasional off-hour support to address time-sensitive production and business-related issues.

Responsibilities

  • Establish and maintain the Andover site validation philosophy and master plan in partnership with local validation program owners, technical subject matter experts, and relevant global, network, and site quality system principals for biologics drug substance and drug substance intermediate production, testing, storage, and transport.
  • Operate the project management office for validation program lifecycle projects.
  • Establish and maintain site governance to interpret validation philosophies and policies, implement and improve uniform validation practices and approaches, and measure and maintain site validation program health.
  • Maintain Site Technical Services departmental infrastructure and provide planning support for third-party services used in validation and other technical services; oversee third-party service-provider service levels and quality of service.
  • Serve as program owner and expert for selected technical and validation disciplines.
  • Plan the Site Technical Services capital project portfolio and expenses.
  • Lead site validation planning and manage validation activities for large capital or complex asset lifecycle projects.
  • Travel domestically and internationally occasionally.

Desired Qualifications

  • Experience developing philosophies or approaches for, or managing, validation programs applicable to manufacturing biopharmaceutical drug substance, drug product, or medical devices.
  • Active participation in an industrial or professional organization focused on advancing biopharmaceutical development, manufacturing, or regulatory practices.
  • Demonstrated ability to lead or build teams for complex technical projects involving risk management.
  • Demonstrated leadership in a matrix organization.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company size
10,001+
Company stage
IPO
Headquarters
New York City, New York
Founded
1849

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