Repligen Corporation

Process Engineer III

Repligen Corporation

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

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Salary

💰 $100,000 - $130,000 per year

Job Level

Mid-LevelSenior

About the role

  • Lead multi-product project execution, manufacturing support, and technology transfer efforts at Rancho Dominguez facility.
  • Provide technical leadership at site level and collaborate with global engineering network to deliver strategic initiatives.
  • Act as Subject Matter Expert for Tangential Flow Filtration (TFF) and other bioprocessing manufacturing systems.
  • Lead projects in equipment design, tech transfer, process validation, and facility upgrades.
  • Plan and execute projects related to the strategic needs of the company.
  • Partner with global engineering teams to support corporate initiatives and site expansion.
  • Identify and implement process improvements ensuring compliance with industry standards and regulations.
  • Develop and maintain engineering documentation including test protocols, change controls, and technical reports.
  • Guide integration of new products and manufacturing processes from early-phase development through commercialization.
  • Mentor junior team members and support standardization and training of best practices.
  • Apply statistical tools to support validation and process optimization efforts.
  • Drive innovation in filtration systems and related support infrastructure to enhance performance and scalability.

Requirements

  • Bachelor’s degree in Engineering required.
  • 5-7 years of experience in medical devices, aerospace, pharmaceuticals, or biologics manufacturing.
  • Hands-on experience with: process validation and equipment qualification; SolidWorks/CAD, MS Office, and electronic file management systems; tech transfer between sites; data analysis and automation; filtration systems (TFF, Hollow Fiber, Flat Sheet Membranes).
  • Strong knowledge of ISO 9001 and GMP manufacturing standards.
  • Familiarity with single-use systems, sterilization techniques, and lean manufacturing principles preferred.
  • Demonstrated ability to lead cross-functional teams and manage projects in a matrixed organization.
  • High level of personal integrity, adaptability, and leadership by example.
  • Capable of independently defining and executing projects.
  • Provides technical direction and feedback to teams across disciplines.
  • Balances day-to-day plant support (40%) with project execution (60%).
  • Communicates clearly with senior leadership on project scope, risks, and progress.
  • Delegates tasks effectively and contributes to team development.
  • Regular work in cleanroom and laboratory environments.
  • Exposure to chemicals, mechanical systems, and occasional electrical hazards.
  • May be required to lift up to 50 lbs and operate in areas with noise and vibration.