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Principal Validation Engineer (Biopharmaceutical)

124 400 - 207 400$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Principal Validation Engineer (Biopharmaceutical): Owning and improving the Andover site validation program and master plan for biopharmaceutical drug substance operations with an accent on validation governance, lifecycle project management, and complex capital projects. Focus on leading site-wide validation planning, managing technical service providers, coordinating cross-functional stakeholders, and ensuring regulatory compliance.

Location: Hybrid, Andover, Massachusetts, United States. Occasional domestic and international travel and off-hour support may be required.

Annual base salary: $124,400–$207,400, plus eligibility for a 17.5% bonus target and share-based long-term incentives.

Company

hirify.global is a pharmaceutical and biopharmaceutical company developing and manufacturing medicines and related products.

What you will do

  • Own the Andover site validation program, philosophy, and master plan for biopharmaceutical drug substance and intermediate production, testing, storage, and transport.
  • Operate the project management office for validation program lifecycle projects.
  • Establish site governance, improve uniform validation practices, and measure validation program health and compliance.
  • Serve as program owner and technical expert for selected validation disciplines.
  • Support capital project portfolio and expense planning, including validation planning for large capital and complex asset lifecycle projects.
  • Maintain technical services infrastructure and oversee third-party validation service quality and service levels.

Requirements

  • BA/BS in Science or Engineering with 6+ years of experience; or MBA/MS with 5+ years; or PhD/JD with 1+ year; or MD/DVM with relevant experience.
  • Experience in the pharmaceutical, biopharmaceutical, or biotechnology industry.
  • Broad knowledge or experience in biopharmaceutical development, manufacturing, and lifecycle management.
  • Experience in project management and leading complex projects.
  • Effective written and verbal communication, strong interpersonal skills, and the ability to collaborate across business functions.
  • Ability to perform mathematical calculations, scientific computation, complex data analysis, verbal communication, and written communication.
  • Candidates must have permanent authorization to work in the United States. U.S. work visa sponsorship is not available now or in the future.

Nice to have

  • Experience developing validation philosophies or approaches, or managing validation programs for biopharmaceutical drug substance, drug product, or medical device manufacturing.
  • Active participation in an industrial or professional organization advancing biopharmaceutical development, manufacturing, or regulatory practices.
  • Ability to lead or build teams for complex technical projects involving risk management.
  • Leadership experience in a matrix organization.

Culture & Benefits

  • Hybrid work location with occasional domestic and international travel.
  • Occasional off-hour support for time-sensitive production and business issues.
  • 401(k) with hirify.global matching and additional retirement savings contributions.
  • Paid vacation, holidays, personal days, caregiver and parental leave, and medical leave.
  • Medical, prescription drug, dental, and vision benefits.

Hiring process

  • Applications must be submitted by July 17, 2026.

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